Acurx Pharmaceuticals Inc (ACXP)

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>>> Acurx Pharmaceuticals to Present at the Microcap Conference, January 31, 2024 - February 1, 2024


PR Newswire

January 23, 2024


https://finance.yahoo.com/news/acurx-pharmaceuticals-present-microcap-conference-120100998.html


STATEN ISLAND, N.Y., Jan. 23, 2024 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. ("Acurx" or the "Company") (NASDAQ: "ACXP"), a late-stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections, today announced that David P. Luci, President & Chief Executive Officer, will be presenting at The Microcap Conference, which will take place January 30, 2024-February 1, 2024 at the Ceasars Atlantic City Hotel & Casino in Atlantic City, New Jersey.

Presentation Details:

Wednesday, January 31st, 2 pm ET and
Thursday, February 1st at 11:40 am ET

Interested parties can register to attend here.

About Acurx Pharmaceuticals, Inc.

Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS®) that blocks the active site of the Gram+ specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin-resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE) and drug-resistant Streptococcus pneumoniae (DRSP).

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>>> Acurx Announces Positive Comparative Microbiology and Microbiome Data for Ibezapolstat from Phase 2b Clinical Trial in CDI Patients


Yahoo Finance

January 17, 2024


https://finance.yahoo.com/news/acurx-announces-positive-comparative-microbiology-120100113.html


Ibezapolstat outperformed vancomycin showing eradication of fecal C. difficile at Day 3 of treatment in 15 of 16 treated patients (94%), versus vancomycin which had eradication of C. difficile in 10 of 14 treated patients (71%).

Ibezapolstat, but not vancomycin, consistently preserved and allowed regrowth of key gut bacterial species believed to confer health benefits including to prevent recurrence of CDI

Further analyses will be forthcoming Q1 2024, as data become available, regarding other endpoints from the Phase 2b trial, including Extended Clinical Cure (ECC) data up to 94 days

Preparation underway for meetings with FDA, European Medicines Agency and other global regulatory agencies and advancement to international Phase 3 clinical trials

Ibezapolstat has previously received FDA QIDP and Fast-Track Designation


STATEN ISLAND, N.Y., Jan. 17, 2024 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a late-stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections, today announced positive comparative microbiology and microbiome data for ibezapolstat, its lead antibiotic candidate, from the Company's recently completed Phase 2b clinical trial in patients with CDI. Data showed that ibezapolstat outperformed vancomycin, a standard of care to treat patients with CDI, with eradication of fecal C. difficile at Day 3 of treatment in 15 of 16 patients (94%) versus vancomycin which had eradication of fecal C. difficile in 10 of 14 patients (71%). In addition, ibezapolstat, but not vancomycin, consistently preserved and allowed regrowth of key gut bacterial species believed to confer health benefits including to prevent CDI recurrence. Further analyses will be forthcoming Q1 2024, as data become available, regarding other endpoints from the Phase 2b trial, including Extended Clinical Cure (ECC) data up to 94 days. Preparation is underway for meetings with FDA, European Medicines Agency and other global regulatory agencies and advancement to international Phase 3 clinical trials.

The Company also announced that a scientific poster will be presented on January 18, 2023 at the Gulf Coast Consortia Antimicrobial Resistance (AMR) Conference in Houston, Texas by Kevin Garey, PharmD, MS, Professor and Chair, University of Houston College of Pharmacy, the Principal Investigator for microbiology and microbiome aspects of the ibezapolstat clinical trial program and Acurx Scientific Advisory Board member. The poster will show comparative data details from the Phase 2b clinical trial entitled: "A Phase 2, Randomized, Double-Blind Study of Ibezapolstat Compared with Vancomycin for the Treatment of Clostridioides difficile Infection."

After the presentation, the poster will be posted on Acurx website: www.acurxpharma.com

According to Dr. Garey: "These results help validate our ongoing scientific investigations into the anti-CDI recurrence effects of ibezapolstat. Our microbiologic findings show that markedly fewer patients treated with ibezapolstat had persistent C. difficile compared to patients treated with vancomycin. He further stated: "Preservation of key health-conferring native gut bacteria, such as Firmicutes, in patients treated with ibezapolstat has now been shown consistently during all clinical studies. These results correlate with prior findings by showing superior preservation of key native gut bacteria compared to vancomycin in CDI patients. Preservation of native gut bacteria during treatment for CDI is believed to be a key component for preventing recurrence of CDI. These findings will need to be further validated in the phase 3 studies but the results to date support the importance of this new class of antibiotics with a novel mechanism of action that does not target native gut bacteria."

Robert J. DeLuccia, Executive Chairman of Acurx, stated: "These new comparative data are very important and timely to enhance our data package for an end of Phase 2 FDA Meeting which is targeted for second quarter this year. He further stated: "Parallel preparations continue on schedule for Phase 3 clinical trials start up later this year, including timely availability of clinical trial supply.

David P. Luci, President & CEO of Acurx, stated: "Ibezapolstat continues to demonstrate success compared to a standard of care, oral vancomycin, to treat patients with CDI. We anticipate that favorable differentiation between the two therapeutic options will continue to be shown in Q1 2024 including extended clinical cure and additional microbiome comparison data. We expect to leverage this success in a $1 billion plus US CDI global market as we move forward with an international Phase 3 clinical trial mandate." He added: "The Company also anticipates its price point for ibezapolstat, if approved, could meet or beat other antibiotics recommended for use in treating patients with CDI, thereby providing the whole package of clinical comparability with microbiome health, safety and cost for patients with this life-threatening disease."

About the Ibezapolstat Phase 2 Clinical Trial

The completed multicenter, open-label single-arm segment (Phase 2a) study was followed by a double-blind, randomized, active-controlled, non-inferiority, segment (Phase 2b) at 28 US clinical trial sites which together comprise the Phase 2 clinical trial. (see https://clinicaltrials.gov/ct2/show/NCT04247542). This Phase 2 clinical trial was designed to evaluate the clinical efficacy of ibezapolstat in the treatment of CDI including pharmacokinetics and microbiome changes from baseline and continue to test for anti- recurrence microbiome properties seen in the Phase 2a trial, including the treatment- related changes in alpha diversity and bacterial abundance and effects on bile acid metabolism.

The completed Phase 2a segment of this trial was an open label cohort of up to 20 subjects from study centers in the United States. In this cohort, 10 patients with diarrhea caused by C. difficile were treated with ibezapolstat 450 mg orally, twice daily for 10 days. All patients were followed for recurrence for 28± 2 days. Per protocol, after 10 patients of the projected 20 Phase 2a patients completed treatment (100% cured infection at End of Treatment), the Trial Oversight Committee assessed the safety and tolerability and made its recommendation regarding early termination of the Phase 2a study and advancement to the Ph2b segment. The Company's Scientific Advisory Board concurred with this recommendation.

In the now completed Phase 2b trial segment, 32 patients with CDI were enrolled and randomized in a 1:1 ratio to either ibezapolstat 450 mg every 12 hours or vancomycin 125 mg orally every 6 hours, in each case, for 10 days and followed for 28 ± 2 days following the end of treatment for recurrence of CDI. The two treatments were identical in appearance, dosing times, and number of capsules administered to maintain the blind. The overall observed Clinical Cure rate in the combined Phase 2 trials in patients with CDI was 96% (25 out of 26 patients), based on 10 out of 10 patients (100%) in Phase 2a in the Modified Intent to Treat Population, plus 15 out of 16 (94%) patients in Phase 2b in the Per Protocol Population, who experienced Clinical Cure during treatment with ibezapolstat. Ibezapolstat was well-tolerated, with three patients each experiencing one mild adverse event assessed by the blinded investigator to be drug-related. All three events were gastrointestinal in nature and resolved without treatment. There were no drug-related treatment withdrawals or no drug-related serious adverse events, or other safety findings of concern. In the Phase 2b vancomycin control arm, 14 out of 14 patients experienced Clinical Cure. The Company is confident that based on the pooled Phase 2 ibezapolstat Clinical Cure rate of 96% and the historical vancomycin cure rate of approximately 81% (Vancocin® Prescribing Information, January 2021), we will demonstrate non-inferiority of ibezapolstat to vancomycin in Phase 3 trials in accordance with the applicable FDA Guidance for Industry (October, 2022).

The Phase 2b clinical trial segment was discontinued due to success. The Company made this decision in consultation with its medical and scientific advisors and statisticians based on observed aggregate blinded data and other factors, including the cost to maintain clinical trial sites and slow enrollment due to COVID-19 and its aftermath. The Company had determined that the trial performed as anticipated for both treatments, ibezapolstat and the control antibiotic vancomycin (a standard of care to treat patients with CDI), with high rates of clinical cure observed across the trial without any emerging safety concerns. Accordingly, an Independent Data Monitoring Committee was not required to perform an interim analysis of this Phase 2b trial data as originally planned. The Company anticipated that this decision would allow the Company to advance this first-in-class, FDA QIDP/Fast Track-designated antibiotic product candidate to Phase 3 clinical trials more expeditiously.

The Phase 2b trial was originally designed to be a non-inferiority (NI) trial and later amended to include an interim efficacy analysis with review by an Independent Data Monitoring Committee (IDMC). The decision to end the trial early based on blinded clinical observations obviated the need for an interim analysis, IDMC review, and NI assessment. The Company determined, in consultation with its clinical and statistical experts, that presenting clinical cure rates for the primary efficacy endpoint is the most appropriate representation for the clinical activity of ibezapolstat in treating CDI.

In the Phase 2 clinical trial, the Company will also evaluate pharmacokinetics (PK) and microbiome changes and test for anti-recurrence microbiome properties, including the change from baseline in alpha diversity and bacterial abundance, especially overgrowth of healthy gut microbiota Actinobacteria and Firmicute phylum species during and after therapy. Phase 2a data demonstrated complete eradication of colonic C. difficile by day three of treatment with ibezapolstat as well as the observed overgrowth of healthy gut microbiota, Actinobacteria and Firmicute phyla species, during and after therapy. Very importantly, emerging data show an increased concentration of secondary bile acids during and following ibezapolstat therapy which is known to correlate with colonization resistance against C. difficile. A decrease in primary bile acids and the favorable increase in the ratio of secondary-to-primary bile acids suggest that ibezapolstat may reduce the likelihood of CDI recurrence when compared to vancomycin.

About Ibezapolstat

Ibezapolstat is a novel, orally administered antibiotic being developed as a Gram-Positive Selective Spectrum (GPSS™) antibacterial. It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections. Ibezapolstat's unique spectrum of activity, which includes C. difficile but spares other Firmicutes and the important Actinobacteria phyla, appears to contribute to the maintenance of a healthy gut microbiome.

In June 2018, ibezapolstat was designated by the U.S. Food and Drug Administration (FDA) as a Qualified Infectious Disease Product (QIDP) for the treatment of patients with CDI and will be eligible to benefit from the incentives for the development of new antibiotics established under the Generating New Antibiotic Incentives Now (GAIN) Act. In January 2019, FDA granted "Fast Track" designation to ibezapolstat for the treatment of patients with CDI. The CDC has designated C. difficile as an urgent threat highlighting the need for new antibiotics to treat CDI.

About Clostridioides difficile Infection (CDI). According to the 2017 Update (published February 2018) of the Clinical Practice Guidelines for C. difficile Infection by the Infectious Diseases Society of America (IDSA) and Society or Healthcare Epidemiology of America (SHEA), CDI remains a significant medical problem in hospitals, in long-term care facilities and in the community. C. difficile is one of the most common causes of health care- associated infections in U.S. hospitals (Lessa, et al, 2015, New England Journal of Medicine). Recent estimates suggest C. difficile approaches 500,000 infections annually in the U.S. and is associated with approximately 20,000 deaths annually. (Guh, 2020, New England Journal of Medicine). Based on internal estimates, the recurrence rate for the antibiotics currently used to treat CDI is between 20% and 40% among approximately 150,000 patients treated. We believe the annual incidence of CDI in the U.S. approaches 600,000 infections and a mortality rate of approximately 9.3%.

About the Microbiome in C. difficile Infection (CDI) and Bile Acid Metabolism

C. difficile can be a normal component of the healthy gut microbiome, but when the microbiome is thrown out of balance, the C. difficile can thrive and cause an infection. After colonization with C. difficile, the organism produces and releases the main virulence factors, the two large clostridial toxins A (TcdA) and B (TcdB). (Kachrimanidou, Microorganisms 2020, 8, 200; doi:10.3390/microorganisms8020200.) TcdA and TcdB are exotoxins that bind to human intestinal epithelial cells and are responsible for inflammation, fluid and mucous secretion, as well as damage to the intestinal mucosa.

Bile acids perform many functional roles in the GI tract, with one of the most important being maintenance of a healthy microbiome by inhibiting C. difficile growth. Primary bile acids, which are secreted by the liver into the intestines, promote germination of C. difficile spores and thereby increase the risk of recurrent CDI after successful treatment of an initial episode. On the other hand, secondary bile acids, which are produced by normal gut microbiota through metabolism of primary bile acids, do not induce C. difficile sporulation and therefore protect against recurrent disease. Since ibezapolstat treatment leads to minimal disruption of the gut microbiome, bacterial production of secondary bile acids continues which may contribute to an anti-recurrence effect. Beneficial effects of bile acids include a decrease in primary bile acids and an increase in secondary bile acids in patients with CDI, which was observed in the Company's Ph2a trial results and previously reported (CID, 2022).

About Acurx Pharmaceuticals, Inc.

Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS®) that blocks the active site of the Gram+ specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin-resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE) and drug-resistant Streptococcus pneumoniae (DRSP).

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The microbiome comparison data is good, so next up is the 94 day extended duration data, which will be the key. In December they released the 1 month sustained cure data, which was a perfect 100% (no relapses), so the 94 day data is next. That 94 day data will determine the strength of upcoming pharma partnering and / or buyout offers.

I figure one reason the stock has been selling off on good news is that they now have an 'ATM' in place (since November), by which they can raise money (up to $17 mil) via the periodic selling of shares into the market. Luci said the first Phase 3 will cost in the $15-18 mil range, and the ATM is how they plan to pay for it, without having to do a big regular type money raise. With the ATM approach they can gradually raise the money over time, so it's an excellent way to raise funds. But for investors it does create the expectation that the company will likely be selling shares into good news, so that expectation can tend to blunt the upside moves in the stock.

Luci has said that his preference 'Plan A' is for an MA (buyout) prior to running the Phase 3. Next preference would be a pharma partner, who will pay for and run the Phase 3s, and third choice is to finish raising the $17 mil via the ATM and run the first Phase 3 in-house, and then partner or MA after that Phase 3 is complete, or has an interim data analysis.

Luci has a finance background, and having the ATM available as a key funding mechanism gives him leverage in pharma negotiations. He has full access to that ATM money, without actually having to do the money raise. The last thing you want in pharma negotiations is for your company to be running on fumes, and the ATM insures that it isn't, so it's a big plus going into negotiations.

Anyway, just my 2 cents..



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[Squeejo]

POS sold off again!!!!

[tw0122]

ACXP good diarrhea trials .. Acurx Announces Positive Comparative Microbiology and Microbiome Data for Ibezapolstat from Phase 2b Clinical Trial in CDI Patients

Source: PR Newswire (US)
Ibezapolstat outperformed vancomycin showing eradication of fecal C. difficile at Day 3 of treatment in 15 of 16 treated patients (94%), versus vancomycin which had eradication of C. difficile in 10 of 14 treated patients (71%).
Ibezapolstat, but not vancomycin, consistently preserved and allowed regrowth of key gut bacterial species believed to confer health benefits including to prevent recurrence of CDI
Further analyses will be forthcoming Q1 2024, as data become available, regarding other endpoints from the Phase 2b trial, including Extended Clinical Cure (ECC) data up to 94 days
Preparation underway for meetings with FDA, European Medicines Agency and other global regulatory agencies and advancement to international Phase 3 clinical trials
Ibezapolstat has previously received FDA QIDP and Fast-Track Designation
STATEN ISLAND, N.Y., Jan. 17, 2024 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a late-stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections, today announced positive comparative microbiology and microbiome data for ibezapolstat, its lead antibiotic candidate, from the Company's recently completed Phase 2b clinical trial in patients with CDI. Data showed that ibezapolstat outperformed vancomycin, a standard of care to treat patients with CDI, with eradication of fecal C. difficile at Day 3 of treatment in 15 of 16 patients (94%) versus vancomycin which had eradication of fecal C. difficile in 10 of 14 patients (71%). In addition, ibezapolstat, but not vancomycin, consistently preserved and allowed regrowth of key gut bacterial species believed to confer health benefits including to prevent CDI recurrence. Further analyses will be forthcoming Q1 2024, as data become available, regarding other endpoints from the Phase 2b trial, including Extended Clinical Cure (ECC) data up to 94 days. Preparation is underway for meetings with FDA, European Medicines Agency and other global regulatory agencies and advancement to international Phase 3 clinical trials.

The Company also announced that a scientific poster will be presented on January 18, 2023 at the Gulf Coast Consortia Antimicrobial Resistance (AMR) Conference in Houston, Texas by Kevin Garey, PharmD, MS, Professor and Chair, University of Houston College of Pharmacy, the Principal Investigator for microbiology and microbiome aspects of the ibezapolstat clinical trial program and Acurx Scientific Advisory Board member. The poster will show comparative data details from the Phase 2b clinical trial entitled: "A Phase 2, Randomized, Double-Blind Study of Ibezapolstat Compared with Vancomycin for the Treatment of Clostridioides difficile Infection."

After the presentation, the poster will be posted on Acurx website: www.acurxpharma.com

According to Dr. Garey: "These results help validate our ongoing scientific investigations into the anti-CDI recurrence effects of ibezapolstat. Our microbiologic findings show that markedly fewer patients treated with ibezapolstat had persistent C. difficile compared to patients treated with vancomycin. He further stated: "Preservation of key health-conferring native gut bacteria, such as Firmicutes, in patients treated with ibezapolstat has now been shown consistently during all clinical studies. These results correlate with prior findings by showing superior preservation of key native gut bacteria compared to vancomycin in CDI patients. Preservation of native gut bacteria during treatment for CDI is believed to be a key component for preventing recurrence of CDI. These findings will need to be further validated in the phase 3 studies but the results to date support the importance of this new class of antibiotics with a novel mechanism of action that does not target native gut bacteria."

Robert J. DeLuccia, Executive Chairman of Acurx, stated: "These new comparative data are very important and timely to enhance our data package for an end of Phase 2 FDA Meeting which is targeted for second quarter this year. He further stated: "Parallel preparations continue on schedule for Phase 3 clinical trials start up later this year, including timely availability of clinical trial supply.

David P. Luci, President & CEO of Acurx, stated: "Ibezapolstat continues to demonstrate success compared to a standard of care, oral vancomycin, to treat patients with CDI. We anticipate that favorable differentiation between the two therapeutic options will continue to be shown in Q1 2024 including extended clinical cure and additional microbiome comparison data. We expect to leverage this success in a $1 billion plus US CDI global market as we move forward with an international Phase 3 clinical trial mandate." He added: "The Company also anticipates its price point for ibezapolstat, if approved, could meet or beat other antibiotics recommended for use in treating patients with CDI, thereby providing the whole package of clinical comparability with microbiome health, safety and cost for patients with this life-threatening disease."

About the Ibezapolstat Phase 2 Clinical Trial
The completed multicenter, open-label single-arm segment (Phase 2a) study was followed by a double-blind, randomized, active-controlled, non-inferiority, segment (Phase 2b) at 28 US clinical trial sites which together comprise the Phase 2 clinical trial. (see https://clinicaltrials.gov/ct2/show/NCT04247542). This Phase 2 clinical trial was designed to evaluate the clinical efficacy of ibezapolstat in the treatment of CDI including pharmacokinetics and microbiome changes from baseline and continue to test for anti- recurrence microbiome properties seen in the Phase 2a trial, including the treatment- related changes in alpha diversity and bacterial abundance and effects on bile acid metabolism.

The completed Phase 2a segment of this trial was an open label cohort of up to 20 subjects from study centers in the United States. In this cohort, 10 patients with diarrhea caused by C. difficile were treated with ibezapolstat 450 mg orally, twice daily for 10 days. All patients were followed for recurrence for 28± 2 days. Per protocol, after 10 patients of the projected 20 Phase 2a patients completed treatment (100% cured infection at End of Treatment), the Trial Oversight Committee assessed the safety and tolerability and made its recommendation regarding early termination of the Phase 2a study and advancement to the Ph2b segment. The Company's Scientific Advisory Board concurred with this recommendation.

In the now completed Phase 2b trial segment, 32 patients with CDI were enrolled and randomized in a 1:1 ratio to either ibezapolstat 450 mg every 12 hours or vancomycin 125 mg orally every 6 hours, in each case, for 10 days and followed for 28 ± 2 days following the end of treatment for recurrence of CDI. The two treatments were identical in appearance, dosing times, and number of capsules administered to maintain the blind. The overall observed Clinical Cure rate in the combined Phase 2 trials in patients with CDI was 96% (25 out of 26 patients), based on 10 out of 10 patients (100%) in Phase 2a in the Modified Intent to Treat Population, plus 15 out of 16 (94%) patients in Phase 2b in the Per Protocol Population, who experienced Clinical Cure during treatment with ibezapolstat. Ibezapolstat was well-tolerated, with three patients each experiencing one mild adverse event assessed by the blinded investigator to be drug-related. All three events were gastrointestinal in nature and resolved without treatment. There were no drug-related treatment withdrawals or no drug-related serious adverse events, or other safety findings of concern. In the Phase 2b vancomycin control arm, 14 out of 14 patients experienced Clinical Cure. The Company is confident that based on the pooled Phase 2 ibezapolstat Clinical Cure rate of 96% and the historical vancomycin cure rate of approximately 81% (Vancocin® Prescribing Information, January 2021), we will demonstrate non-inferiority of ibezapolstat to vancomycin in Phase 3 trials in accordance with the applicable FDA Guidance for Industry (October, 2022).

The Phase 2b clinical trial segment was discontinued due to success. The Company made this decision in consultation with its medical and scientific advisors and statisticians based on observed aggregate blinded data and other factors, including the cost to maintain clinical trial sites and slow enrollment due to COVID-19 and its aftermath. The Company had determined that the trial performed as anticipated for both treatments, ibezapolstat and the control antibiotic vancomycin (a standard of care to treat patients with CDI), with high rates of clinical cure observed across the trial without any emerging safety concerns. Accordingly, an Independent Data Monitoring Committee was not required to perform an interim analysis of this Phase 2b trial data as originally planned. The Company anticipated that this decision would allow the Company to advance this first-in-class, FDA QIDP/Fast Track-designated antibiotic product candidate to Phase 3 clinical trials more expeditiously.

The Phase 2b trial was originally designed to be a non-inferiority (NI) trial and later amended to include an interim efficacy analysis with review by an Independent Data Monitoring Committee (IDMC). The decision to end the trial early based on blinded clinical observations obviated the need for an interim analysis, IDMC review, and NI assessment. The Company determined, in consultation with its clinical and statistical experts, that presenting clinical cure rates for the primary efficacy endpoint is the most appropriate representation for the clinical activity of ibezapolstat in treating CDI.

In the Phase 2 clinical trial, the Company will also evaluate pharmacokinetics (PK) and microbiome changes and test for anti-recurrence microbiome properties, including the change from baseline in alpha diversity and bacterial abundance, especially overgrowth of healthy gut microbiota Actinobacteria and Firmicute phylum species during and after therapy. Phase 2a data demonstrated complete eradication of colonic C. difficile by day three of treatment with ibezapolstat as well as the observed overgrowth of healthy gut microbiota, Actinobacteria and Firmicute phyla species, during and after therapy. Very importantly, emerging data show an increased concentration of secondary bile acids during and following ibezapolstat therapy which is known to correlate with colonization resistance against C. difficile. A decrease in primary bile acids and the favorable increase in the ratio of secondary-to-primary bile acids suggest that ibezapolstat may reduce the likelihood of CDI recurrence when compared to vancomycin.

About Ibezapolstat
Ibezapolstat is a novel, orally administered antibiotic being developed as a Gram-Positive Selective Spectrum (GPSS™) antibacterial. It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections. Ibezapolstat's unique spectrum of activity, which includes C. difficile but spares other Firmicutes and the important Actinobacteria phyla, appears to contribute to the maintenance of a healthy gut microbiome.

In June 2018, ibezapolstat was designated by the U.S. Food and Drug Administration (FDA) as a Qualified Infectious Disease Product (QIDP) for the treatment of patients with CDI and will be eligible to benefit from the incentives for the development of new antibiotics established under the Generating New Antibiotic Incentives Now (GAIN) Act. In January 2019, FDA granted "Fast Track" designation to ibezapolstat for the treatment of patients with CDI. The CDC has designated C. difficile as an urgent threat highlighting the need for new antibiotics to treat CDI.

About Clostridioides difficile Infection (CDI). According to the 2017 Update (published February 2018) of the Clinical Practice Guidelines for C. difficile Infection by the Infectious Diseases Society of America (IDSA) and Society or Healthcare Epidemiology of America (SHEA), CDI remains a significant medical problem in hospitals, in long-term care facilities and in the community. C. difficile is one of the most common causes of health care- associated infections in U.S. hospitals (Lessa, et al, 2015, New England Journal of Medicine). Recent estimates suggest C. difficile approaches 500,000 infections annually in the U.S. and is associated with approximately 20,000 deaths annually. (Guh, 2020, New England Journal of Medicine). Based on internal estimates, the recurrence rate for the antibiotics currently used to treat CDI is between 20% and 40% among approximately 150,000 patients treated. We believe the annual incidence of CDI in the U.S. approaches 600,000 infections and a mortality rate of approximately 9.3%.

About the Microbiome in C. difficile Infection (CDI) and Bile Acid Metabolism
C. difficile can be a normal component of the healthy gut microbiome, but when the microbiome is thrown out of balance, the C. difficile can thrive and cause an infection. After colonization with C. difficile, the organism produces and releases the main virulence factors, the two large clostridial toxins A (TcdA) and B (TcdB). (Kachrimanidou, Microorganisms 2020, 8, 200; doi:10.3390/microorganisms8020200.) TcdA and TcdB are exotoxins that bind to human intestinal epithelial cells and are responsible for inflammation, fluid and mucous secretion, as well as damage to the intestinal mucosa.

Bile acids perform many functional roles in the GI tract, with one of the most important being maintenance of a healthy microbiome by inhibiting C. difficile growth. Primary bile acids, which are secreted by the liver into the intestines, promote germination of C. difficile spores and thereby increase the risk of recurrent CDI after successful treatment of an initial episode. On the other hand, secondary bile acids, which are produced by normal gut microbiota through metabolism of primary bile acids, do not induce C. difficile sporulation and therefore protect against recurrent disease. Since ibezapolstat treatment leads to minimal disruption of the gut microbiome, bacterial production of secondary bile acids continues which may contribute to an anti-recurrence effect. Beneficial effects of bile acids include a decrease in primary bile acids and an increase in secondary bile acids in patients with CDI, which was observed in the Company's Ph2a trial results and previously reported (CID, 2022).

[gfp927z]

The replay of the Jan 11 JP Morgan presentation is up on Acurx's website (links below). Luci said all the remaining data should be out in Jan, and includes the extended durability (94 day), microbiome comparison data, and microbiology comparison data. So the next 2 weeks should be very interesting :o)


https://d3ua9t66dzwd8a.cloudfront.net/HC24/p_50099_Acurx.mp3


https://ir.acurxpharma.com/





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The JP Morgan conference presentation is tomorrow, and there was also a new Fox interview with Luci (below) that aired last Monday (interview was taped before Christmas). So anticipation is building :o)

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>>> Acurx to present at the 42nd Annual J.P. Morgan Healthcare Conference


PR Newswire

January 3, 2024


https://finance.yahoo.com/news/acurx-present-42nd-annual-j-130000189.html


STATEN ISLAND, N.Y., Jan. 3, 2024 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company") today announced that President and Chief Executive Officer David P. Luci will present at the 42nd Annual J.P. Morgan Healthcare Conference on Thursday, January 11, 2024 at 12:00 pm PST. An audio webcast of the presentation will be available live at https://jpmorgan.metameetings.net/events/healthcare24/sessions/50099-acurx-pharmaceuticals-inc/webcast?gpu_only=true&kiosk=true and will be available upon completion of the conference on the Company's website at www.acurxpharma.com under the Investors section.

About Acurx Pharmaceuticals, Inc.

Acurx Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing new antibiotics for difficult to treat infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS®) that blocks the active site of the Gram+ specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin-resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE) and drug-resistant Streptococcus pneumoniae (DRSP).

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[Squeejo]

9:37
News Detail
TT
pharmaurials ost From 13, Keeps Acr
9:06 AM ET 12/15/2023 | MT Newswires
????
--HC Wainwright Adjusts Price Target on Acurx Pharmaceuticals to $14 From $13, Keeps Buy Rating
09:06 AM EST, 12/15/2023 (MT Newswires) -- (MT
Newswires covers equity, commodity and economic research from major banks and research firms in North America, Asia and Europe. Research providers may contact us here: https:// www.mtnewswires.com/contact-us)
Price: 3.48, Change: +0.12, Percent Change:
+3.57

[gfp927z]

The 1 month durability data looks great though, so next will be the 94 day data in Jan. Looks like Ibexa is performing exactly as hoped, while Vancomycin is moving toward it's historically poor recurrence rate. We know Ibeza spares the healthy microbiome, while Vanc destroys it, so over time the differential should expand even more in Ibeza's favor. The excellent 1 month durability data (100%) de-risks the stock and makes it a far safer long term buy / hold imo.

Today's 'sell on the news' activity was on fairly high volume, so some of the selling might be related to the warrant shares (?) If so, then Acurx gets some additional non-dilutive cash coming in. In the Nov 14 conference call, CEO Luci said that up to $15 mil could potentially be obtained via the exercise of the existing warrants.

Anyway, next up will be the 94 day durability data (Jan), and the microbiome data. So here's hoping for continued success :o)




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[Squeejo]

3.47 close POS

[Squeejo]

And we tank 10 percent😢😢😢

[gfp927z]

>>> Acurx Announces Positive Phase 2b Results Showing 100% of Patients Who Had Clinical Cure with Ibezapolstat Also Had Sustained Clinical Cure


PR Newswire

December 11, 2023


https://finance.yahoo.com/news/acurx-announces-positive-phase-2b-120100375.html


All 15 ibezapolstat-treated patients in Phase 2b who achieved Clinical Cure (CC) at end of treatment (EOT) remained free of C. difficile Infection (CDI) recurrence through one month after EOT, for a Sustained Clinical Cure (SCC) rate of 100%

2 of 14 patients treated with standard of care, oral vancomycin, experienced recurrent infection within one month after EOT for a SCC of 86%

100% of the 25 ibezapolstat-treated patients in Phase 2 (Phase 2a and 2b) who had CC at EOT remained cured through one month after EOT

Further analyses will be forthcoming Q1 2024, as data become available, regarding other endpoints, from the Phase 2b trial, including Extended Clinical Cure (ECC) data up to 94 days and comparative effects vs vancomycin on the gut microbiome

Preparation underway for meetings with FDA, European Medicines Agency and other global regulatory agencies and advancement to international Phase 3 clinical trials


STATEN ISLAND, N.Y., Dec. 11, 2023 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a late-stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections, today announced positive Phase 2b results showing 100% of CDI patients who had CC with ibezapolstat, the company's late-stage antibiotic candidate, also had SCC.

The efficacy results from the Phase 2 trial (Phase 2a and Phase 2b) are summarized in the table below:

Clinical Cure
(CC)

at EOT

Sustained Clinical Cure
(SCC)

One Month After EOT for
all evaluable patients

Sustained

Clinical Cure* (SCC) One
Month After EOT

ibezapolstat Phase 2a

10/10 (100%)

10/10 (100%)

10/10 (100%)

ibezapolstat Phase 2b

15/16 (94%)

15/16 (94%)

15/15 (100%)

ibezapolstat Phase 2a +

Phase 2b Combined

25/26 (96%)

25/26 (96%)

25/25 (100%)

vancomycin

14/14 (100%)

12/14 (86%)

12/14 (86%)

*Sustained Clinical Cure was evaluated only for patients who were CC at EOT.

Kevin Garey, PharmD, MS, Professor and Chair, University of Houston College of Pharmacy, the Principal Investigator for microbiome aspects of the ibezapolstat clinical trial program and Acurx Scientific Advisory Board member stated: "These results help validate our ongoing scientific investigations into the anti-CDI recurrence properties of ibezapolstat including maintenance and regrowth of healthy gut microbes and bile acid homeostasis. I'm excited about our ongoing investigations into a new scientific paradigm optimizing C. difficile antibiotic development to effectively cure CDI and prevent recurrence."

According to Stuart Johnson, MD, Professor of Medicine, Loyola University (Infectious Disease) and Acurx Scientific Advisory Board member: "Treatment of CDI remains an important unmet medical need, for 2 reasons. First, the potential for development of resistance in C. difficile to currently available drugs like vancomycin threatens our standard therapeutic approach. Second, recurrent disease is a very serious problem with limited available treatment options. Although vancomycin is still an effective treatment, CDI patients treated with oral vancomycin experience a recurrence rate of 18-23%. Ibezapolstat, by virtue of its novel mechanism of action, lack of cross-resistance with any marketed antibiotics, narrow antibacterial spectrum, and selective effects on the gut microbiome, appears to be a promising potential new addition to our therapeutic armamentarium. I continue to be encouraged by the accumulating data showing that ibezapolstat is clinically comparable to vancomycin in treating CDI and preventing recurrence."

Robert J. DeLuccia, Executive Chairman of Acurx, stated: "The overall Phase 2 data demonstrate a high clinical cure rate of 96% together with this 100% recurrence-free rate is a promising one-two punch to C. difficile infection for a potential front-line treatment option for patients with CDI." He further stated: "These two clinical trial endpoints, together with the Phase 1 and Phase 2a clinical trial data and with additional data analyses to come, will form the basis for a comprehensive, solid data package to present to global regulatory authorities to support advancement to Phase 3 clinical trials during the second half next year and move one step closer on its pathway to commercialization."

David P. Luci, President & CEO of Acurx, stated: "Ibezapolstat continues to demonstrate success compared to a standard of care, oral vancomycin, to treat patients with CDI. We anticipate favorable separation between the two therapeutic options will continue in Q1 2024 with extended clinical cure and microbiome comparison data. We expect to leverage this success in a $1 billion plus US CDI market internationally as we move forward with an international Phase 3 clinical trial mandate." He added: "The Company also announced its "Made in America" policy initiative for manufacture of ibezapolstat capsules for Phase 3 clinical trials and commercial supply to ensure patients have uninterrupted access to this potentially life-saving antibiotic mitigating potential supply chain disruptions."

About the Ibezapolstat Phase 2 Clinical Trial

The completed multicenter, open-label single-arm segment (Phase 2a) study was followed by a double-blind, randomized, active-controlled, non-inferiority, segment (Phase 2b) at 28 US clinical trial sites which together comprise the Phase 2 clinical trial (see https://clinicaltrials.gov/ct2/show/NCT04247542). This Phase 2 clinical trial was designed to evaluate the clinical efficacy of ibezapolstat in the treatment of CDI

including pharmacokinetics and microbiome changes from baseline and continue to test for anti- recurrence microbiome properties seen in the Phase 2a trial, including the treatment- related changes in alpha diversity and bacterial abundance and effects on bile acid metabolism.

The completed Phase 2a segment of this trial was an open label cohort of up to 20 subjects from study centers in the United States. In this cohort, 10 patients with diarrhea caused by C. difficile were treated with ibezapolstat 450 mg orally, twice daily for 10 days. All patients were followed for recurrence for 28± 2 days. Per protocol, after 10 patients of the projected 20 Phase 2a patients completed treatment (100% cured infection at End of Treatment), the Trial Oversight Committee assessed the safety and tolerability and made its recommendation regarding early termination of the Phase 2a study and advancement to the Ph2b segment. The Company's Scientific Advisory Board concurred with this recommendation.

In the now completed Phase 2b trial segment, 32 patients with CDI were enrolled and randomized in a 1:1 ratio to either ibezapolstat 450 mg every 12 hours or vancomycin 125 mg orally every 6 hours, in each case, for 10 days and followed for 28 ± 2 days following the end of treatment for recurrence of CDI. The two treatments were identical in appearance, dosing times, and number of capsules administered to maintain the blind. The overall observed Clinical Cure rate in the combined Phase 2 trials in patients with CDI was 96% (25 out of 26 patients), based on 10 out of 10 patients (100%) in Phase 2a in the Modified Intent to Treat Population, plus 15 out of 16 (94%) patients in Phase 2b in the Per Protocol Population, who experienced Clinical Cure during treatment with ibezapolstat. Ibezapolstat was well-tolerated, with three patients each experiencing one mild adverse event assessed by the blinded investigator to be drug-related. All three events were gastrointestinal in nature and resolved without treatment. There were no drug-related treatment withdrawals or no drug-related serious adverse events, or other safety findings of concern. In the Phase 2b vancomycin control arm, 14 out of 14 patients experienced Clinical Cure. The Company is confident that based on the pooled Phase 2 ibezapolstat Clinical Cure rate of 96% and the historical vancomycin cure rate of approximately 81% (Vancocin® Prescribing Information, January 2021), we will demonstrate non-inferiority of ibezapolstat to vancomycin in Phase 3 trials in accordance with the applicable FDA Guidance for Industry (October, 2022).

The Phase 2b clinical trial segment was discontinued due to success. The Company made this decision in consultation with its medical and scientific advisors and statisticians based on observed aggregate blinded data and other factors, including the cost to maintain clinical trial sites and slow enrollment due to COVID-19 and its aftermath. The Company had determined that the trial performed as anticipated for both treatments, ibezapolstat and the control antibiotic vancomycin (a standard of care to treat patients with CDI), with high rates of clinical cure observed across the trial without any emerging safety concerns. Accordingly, an Independent Data Monitoring Committee was not required to perform an interim analysis of this Phase 2b trial data as originally planned. The Company anticipated that this decision would allow the Company to advance this first-in-class, FDA QIDP/Fast Track-designated antibiotic product candidate to Phase 3 clinical trials more expeditiously.

The Phase 2b trial was originally designed to be a non-inferiority (NI) trial and later amended to include an interim efficacy analysis with review by an Independent Data Monitoring Committee (IDMC). The decision to end the trial early based on blinded clinical observations obviated the need for an interim analysis, IDMC review, and NI assessment. The Company determined, in consultation with its clinical and statistical experts, that presenting clinical cure rates for the primary efficacy endpoint is the most appropriate representation for the clinical activity of ibezapolstat in treating CDI.

In the Phase 2 clinical trial, the Company will also evaluate pharmacokinetics (PK) and microbiome changes and test for anti-recurrence microbiome properties, including the change from baseline in alpha diversity and bacterial abundance, especially overgrowth of healthy gut microbiota Actinobacteria and Firmicute phylum species during and after therapy. Phase 2a data demonstrated complete eradication of colonic C. difficile by day three of treatment with ibezapolstat as well as the observed overgrowth of healthy gut microbiota, Actinobacteria and Firmicute phyla species, during and after therapy. Very importantly, emerging data show an increased concentration of secondary bile acids during and following ibezapolstat therapy which is known to correlate with colonization resistance against C. difficile. A decrease in primary bile acids and the favorable increase in the ratio of secondary-to-primary bile acids suggest that ibezapolstat may reduce the likelihood of CDI recurrence when compared to vancomycin.

About Ibezapolstat

Ibezapolstat is a novel, orally administered antibiotic being developed as a Gram-Positive Selective Spectrum (GPSS™) antibacterial. It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections. Ibezapolstat's unique spectrum of activity, which includes C. difficile but spares other Firmicutes and the important Actinobacteria phyla, appears to contribute to the maintenance of a healthy gut microbiome.

In June 2018, ibezapolstat was designated by the U.S. Food and Drug Administration (FDA) as a Qualified Infectious Disease Product (QIDP) for the treatment of patients with CDI and will be eligible to benefit from the incentives for the development of new antibiotics established under the Generating New Antibiotic Incentives Now (GAIN) Act. In January 2019, FDA granted "Fast Track" designation to ibezapolstat for the treatment of patients with CDI. The CDC has designated C. difficile as an urgent threat highlighting the need for new antibiotics to treat CDI.

About Clostridioides difficile Infection (CDI). According to the 2017 Update (published February 2018) of the Clinical Practice Guidelines for C. difficile Infection by the Infectious Diseases Society of America (IDSA) and Society or Healthcare Epidemiology of America (SHEA), CDI remains a significant medical problem in hospitals, in long-term care facilities and in the community. C. difficile is one of the most common causes of health care- associated infections in U.S. hospitals (Lessa, et al, 2015, New England Journal of Medicine). Recent estimates suggest C. difficile approaches 500,000 infections annually in the U.S. and is associated with approximately 20,000 deaths annually. (Guh, 2020, New England Journal of Medicine). Based on internal estimates, the recurrence rate for the antibiotics currently used to treat CDI is between 20% and 40% among approximately 150,000 patients treated. We believe the annual incidence of CDI in the U.S. approaches 600,000 infections and a mortality rate of approximately 9.3%.

About the Microbiome in C. difficile Infection (CDI) and Bile Acid Metabolism

C. difficile can be a normal component of the healthy gut microbiome, but when the microbiome is thrown out of balance, the C. difficile can thrive and cause an infection. After colonization with C. difficile, the organism produces and releases the main virulence factors, the two large clostridial toxins A (TcdA) and B (TcdB). (Kachrimanidou, Microorganisms 2020, 8, 200; doi:10.3390/microorganisms8020200.) TcdA and TcdB are exotoxins that bind to human intestinal epithelial cells and are responsible for inflammation, fluid and mucous secretion, as well as damage to the intestinal mucosa.

Bile acids perform many functional roles in the GI tract, with one of the most important being maintenance of a healthy microbiome by inhibiting C. difficile growth. Primary bile acids, which are secreted by the liver into the intestines, promote germination of C. difficile spores and thereby increase the risk of recurrent CDI after successful treatment of an initial episode. On the other hand, secondary bile acids, which are produced by normal gut microbiota through metabolism of primary bile acids, do not induce C. difficile sporulation and therefore protect against recurrent disease. Since ibezapolstat treatment leads to minimal disruption of the gut microbiome, bacterial production of secondary bile acids continues which may contribute to an anti-recurrence effect. Beneficial effects of bile acids include a decrease in primary bile acids and an increase in secondary bile acids in patients with CDI, which was observed in the Company's Ph2a trial results and previously reported (CID, 2022).

About Acurx Pharmaceuticals, Inc.

Acurx Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing new antibiotics for difficult to treat infections. The Company's approach is to develop antibiotic candidates with a Gram-positive selective spectrum (GPSS®) that blocks the active site of the Gram+ specific bacterial enzyme DNA polymerase IIIC (pol IIIC), inhibiting DNA replication and leading to Gram-positive bacterial cell death. Its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin-resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE) and drug-resistant Streptococcus pneumoniae (DRSP).

<<<



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[Awl416]

Acurx Announces Positive Phase 2b Results Showing 100% of Patients Who Had Clinical Cure with Ibezapolstat Also Had Sustained Clinical Cure

[gfp927z]

CEO interview -

This is actually the same interview from two weeks ago (below), but a good overview. The next few weeks should be very interesting, and then more data to come in Jan and Feb. Here's the general timeline given from the Nov 14 conference call. The key (imo) will be the 94 day data -

Dec ------------ Sustained Clinical Cure data
Dec or Jan --- Extended Clinical Cure data up to 94 days
Jan or Feb --- Impact on Microbiome data
March --------- End of Phase 2 meeting with FDA


Summary - https://investorshub.advfn.com/boards/read_msg.aspx?message_id=173224909

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[gfp927z]

An Acurx interview tonight with Bloomberg TV (see below), so this could be part of the catalyst for today's jump in the stock.

As we know, the first batch of durability data should be released in Dec, per CEO Luci's previous guidance. Then the next batch (day 94 data) should be ~ Jan, and then the microbiome data. So a 3 stage release of data over the next few months to make things interesting :o)

I figure the 94 day durability data in Jan is the most important, with the Dec data being the lead up. If the Dec data is clearly positive the stock should zoom. If it's ambiguous, then we wait for the 94 day data in Jan, and the microbiome data. As a bio 'binary event' this is unusual, since a disappointment in Dec can be made moot by good news in Jan. So this de-risks the stock considerably. We already know that Ibex leaves the microbiome relatively intact, compared to Vancomycin, so Ibez's 'recurrence advantage' should increase over time, which makes for excellent odds with the 94 day data.

All IMHO :o)



>>> NEW YORK, Dec. 07, 2023 (GLOBE NEWSWIRE) -- FMW Media's New to The Street announces its corporate interview lineup for its business show airing as a sponsored program on Bloomberg TV tonight, Thursday, December 7, 2023, at 9:30 PM PT.

... 3) Biopharmaceutical - Acurx Pharmaceuticals, Inc.'s (NASDAQ: ACXP) ($ACXP) interview with David Luci, President/CEO.


https://finance.yahoo.com/news/street-tv-announces-episode-536-142000722.html


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[Squeejo]

After listening to the recent conference call and the new to the street interview with doctor Luci, I believe they have a paying partner to take them through stage 3 clinical.
Just my take, we shall see.

[Jeff4iam4]

Yep, expecting good data released these next few months and then competitive bids from several big pharmaceuticals ( Pfizer and Merck being the two most interested) in a buyout. Fully diluted share price is likely going to be in the neighborhood of $20 to $32 a share. My likely scenario is about $24 to $26.

[Squeejo]

Institutional investment has increased!
NDA signed with multiple suitors !
ACXP is getting its running shoes tied!!!!!

[Jeff4iam4]

Get them while still cheap. Buyout likely within next few months, probably by April or May at latest. Target buyout is between $20 to $38 a share. But I would not expect more than $24 due to the fact we are not in Phase 3 yet. CEO is on record that he is actively looking for a buyout forth-most or as secondary BP partner to fund the Phase 3. No way they do a offering to go Phase 3 alone and dilute the shares further. He wants to pass the burden of Phase 3 and FDA approval to a company with resources that can get this drug to market quickly. He is heavily invested not just with warrants, but with his own personal money as are a few other company officials. He also has a record of 4 out of 5 companies he has sold off after Phase 2 trials for major profit, so he is very experienced with Mergers/Acquisitions. Top line data came out showing a 94% cure rate in Phase 2b trial and 100% in the 2a trial in the past creating a 96% overall cure rate. The full data from phase 2b will be out by December and if it shows clear separation in sustained cure over Vancomycin (current standard of care drug) then this company will be easily sold to competitive bidding by several BPs. The chances of showing that separation of sustainable cure rate is high as it was shown to be 100% in the previous 2a trial.

[gfp927z]

Pasteur Act -- >>> Bennet, Young, Bipartisan House Colleagues Reintroduce Bipartisan PASTEUR Act to Fight Antimicrobial Resistance


April 27, 2023


https://www.bennet.senate.gov/public/index.cfm/2023/4/bennet-young-bipartisan-house-colleagues-reintroduce-bipartisan-pasteur-act-to-fight-antimicrobial-resistance


Bipartisan, Bicameral Legislation Would Support Development of Innovative Antibiotics to Treat Resistant Infections and Improve Appropriate Antibiotic Use

Washington, D.C. — Today, Colorado U.S. Senator Michael Bennet and U.S. Senator Todd Young (R-Ind.), alongside U.S. Representatives Scott Peters (D-Calif.), Drew Ferguson (R-Ga.), Mike Levin (D-Calif.), and Jake LaTurner (R-Kan.) reintroduced the Pioneering Antimicrobial Subscriptions to End Upsurging Resistance (PASTEUR) Act to encourage innovative drug development targeting the most threatening infections, improve the appropriate use of antibiotics, and ensure domestic availability of antibiotics when needed.

“Right now, we don’t have the tools to address the threat posed by antimicrobial resistance – and infectious disease experts are warning us that it will only get worse,” said Bennet. “The bipartisan PASTEUR Act is the strongest bill ever written to strengthen antibiotic development and use. It will fix our market failures, expand the pipeline for next generation antibiotics, and save lives. We can’t sit on our hands as this public health crisis arrives – we have to act now.”

“Americans understand that we must take every reasonable and responsible measure to prevent future public health crises. Antimicrobial resistance has become a growing crisis in recent years. Market failures have resulted in a lack of needed research and development in this field which is a threat to public health. Our bill would incentivize the development of new innovative antibiotics and focus on educating health care providers on how to avoid overuse or misuse of these life-saving medications in order to slow the emergence of antibiotic-resistant pathogens,” said Young.

“Antimicrobial resistance poses a growing and significant threat to Americans’ health,” said Peters. “The PASTEUR Act will help us develop better antibiotics to counter resistant infections and help doctors ensure these drugs are used responsibly to stop the emergence of new superbugs. In the wake of the COVID-19 pandemic, we must do everything in our power to prevent the next public health crisis.”

“Antibiotics make modern medicine possible and the U.S. is at risk of losing these critical drugs. Antibiotic resistant infections are becoming more commonplace, and Congress must take action so that the foundation of modern medicine doesn’t crumble,” said Ferguson. “The PASTEUR Act brings together the public and private sectors to address these drug development market failures, increase public health preparedness, and help usher in a new era of antibiotic development. This essential legislation will also improve appropriate antibiotic use across the healthcare system while enhancing and safeguarding new antibiotic development. Simply put, we must act now to keep research and development from falling behind.”

“Each year in the United States, at least 2.8 million people become infected with pathogens that are resistant to treatment and for which advanced antimicrobials are needed. Unfortunately, as the COVID-19 pandemic made clear, our country needs stronger resources to develop those antimicrobials and prevent another global pandemic,” said Levin. “Our PASTEUR ACT empowers the Department of Health and Human Services to seek expertise on the development of antimicrobials and devise a plan to make them widely available. I thank Sen. Bennet and Rep. Ferguson for leading this bicameral, bipartisan legislation and look forward to it moving through the legislative process.”

“The COVID-19 pandemic reminded us how crucial it is for our nation to continue investing in healthcare research to prevent future public health emergencies,” said LaTurner. “America can't afford to be asleep at the wheel when it comes to the threat of antimicrobial resistance. That's why I'm proud to join my colleagues in introducing the bipartisan PASTEUR Act to bolster new antibiotic development and help medical professionals prevent the overuse of lifesaving drugs.”

According to the Centers for Disease Control and Prevention’s (CDC) Antibiotic Resistance Threats in the United States report, more than 2.8 million antibiotic-resistant infections occur in the United States each year, and at least 35,000 people die as a result. In March 2015, the U.S. National Action Plan for Combating Antibiotic-Resistant Bacteria directed federal agencies to accelerate a coordinated, full government response to antibiotic resistance and take action to expand the ability of our health care system to prevent, identify, and respond to the infection pandemic threat posed by antimicrobial resistance. Part of this plan was to increase and incent development of innovative antimicrobial drugs to treat resistant infections. Because of severe market failures in the health care system, many of the innovative antibiotic companies doing this work have filed for bankruptcy and stopped producing their critical drugs completely.

The PASTEUR Act would address this market failure and increase public health preparedness by keeping novel antibiotics on the market and improving appropriate use across the health care system. While current contracts between the government and drug makers base payment on volume, the PASTEUR Act would establish a subscription-style model which would offer antibiotic developers an upfront payment in exchange for access to their antibiotics, encouraging innovation and ensuring our health care system is prepared to treat resistant infections.

Statements of Support

“Millions will continue to die from resistant bacteria because we are out of treatment options. Antibiotics aren't working any more for most people who contract a superbug. The science is extraordinary, it's the business model that's broken. We desperately need a new way to pay for these drugs - antibiotics, antifungals, and phage therapy. The Pasteur Act is that rare, bipartisan idea that solves an incredible problem for an affordable price,” said Professor Kevin Outterson, Boston University.

“Antibiotics play a vital role in modern medicine, and we know that preserving access to these drugs is essential to any pandemic or public health emergency response. Yet the medicines that the U.S. relies on to treat serious infections have remained largely the same for nearly 40 years and are increasingly ineffective against quickly evolving bacteria. In 2023, the U.S. has already experienced several alarming antibiotic-resistant threats—and the emergence of new superbugs will continue and will only get worse. The bipartisan PASTEUR Act has the support of a diverse group of more than 230 public health and health care organizations, because it will help us fix the broken antibiotic drug pipeline and deliver important new therapies to physicians and the patients who need them. Reintroduction of the bill is an encouraging sign that policymakers remain committed to ensuring that lifesaving antibiotics are available when Americans need them most,” said David Hyun, director of The Pew Charitable Trusts’ Antibiotic Resistance Project.

"The need for legislative solutions to address the public health challenges posed by antimicrobial resistance (AMR) has been mounting for quite some time now, and we applaud the sponsors of the PASTEUR Act for their leadership. This bill will make new novel antibiotics a reality for patients and providers and fortify our healthcare system for future generations. AMR impacts us all and protection against the increasing threats of infection is not a partisan issue. We encourage broad support and quick passage of the PASTEUR Act,” said Candace DeMatteis, Vice President of Policy, Partnership to Fight Infectious Disease.

"For decades, we have seen antimicrobial resistance (AMR) soar around the world, while the pipeline for new treatments slows to a trickle due to the broken ecosystem for antimicrobial innovation. The PASTEUR Act is an integral solution to addressing the global public health crisis of AMR. The bipartisan bill will help repair the foundational challenges of the antimicrobial marketplace and drive the development of new, innovative treatments for patients,” said Rachel King, Interim President and CEO of the Biotechnology Innovation Organization.

“Infectious diseases physicians see firsthand the devastating impact of antimicrobial-resistant infections on our patients. We urgently need novel antimicrobials and investments in antimicrobial stewardship to preserve the efficacy of these precious drugs and optimize patient outcomes. The PASTEUR Act will deliver the tools we need to protect modern medicine and strengthen our preparedness for future emergencies,” said Carlos del Rio, MD, FIDSA, President, Infectious Diseases Society of America; and Interim Dean, Emory University School of Medicine.

“For people living with cystic fibrosis, difficult-to-treat infections are an unfortunate but common occurrence, and the fear of not having enough treatment options is an all too familiar concern. There is an urgent need to pass the PASTEUR Act to help ensure availability of novel antibiotics, not only for the CF community today, but for patients everywhere who could face a public health crisis tomorrow if Congress refuses to take action now,” said Mary Dwight, Senior Vice President and Chief Policy and Advocacy Officer, Cystic Fibrosis Foundation.

“Patients with drug resistant diseases are defenseless without new treatments, many of us are fighting rare diseases and we desperately need the treatments supported by the PASTEUR Act. PASTEUR is a bill for patients, and without it, too many of us will not survive our fight and those that do are facing a reduced quality of life. The new treatments created through the PASTEUR Act could one day cure me and others fighting disease with limited or no treatment options. Until then, I wake up every day hoping the medications available do not fail me again,” said Rob Purdie, Cofounder, MyCARE (MyCology Advocacy, Research & Education).

Specifically, the PASTEUR Act would:

Establish a subscription model to encourage innovative antimicrobial drug development aimed at treating drug-resistant infections. This model will be fully delinked, meaning that participating developers would not receive income, as a part of their subscription payments, based on volume or quantity of sales.

Subscription contracts would contain terms and conditions including product availability to individuals on a government health insurance plan, supporting appropriate use, and completion of postmarketing studies. These contracts could be valued between $750 million and $3 billion.

Build on existing frameworks to improve usage of the CDC National Healthcare Safety Network, the Emerging Infections Program, and other programs to collect and report on antibiotic use and resistance data.

Include transition measures such as smaller subscription contracts to support novel antimicrobial drug developers that need a financial lifeline.

Form a Committee on Critical Need Antimicrobials, consisting of representatives from federal agencies, doctors, patients, and outside experts, to develop and implement necessary guidance regarding infections of concern, and the favored characteristics of potential treatments.

Bennet and Young first introduced the PASTEUR Act in September 2020.

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[gfp927z]

>>> Acurx Announces Ibezapolstat Scientific Posters and Presentations at ClostPath 2023 and IDWeek 2023 Scientific Conferences


PR Newswire

October 19, 2023


https://finance.yahoo.com/news/acurx-announces-ibezapolstat-scientific-posters-110100090.html


Three scientific posters highlighting novel anti-virulence pharmacologic properties of oral ibezapolstat for C. difficile Infection; effects on toxin production, biofilm and the gut microbiome

A podium presentation entitled First of a New Class of Antibiotics (pol IIIC Inhibitors) Targeting CDC/FDA/WHO Priority Pathogens; Preparing for the Next Pandemic: Antimicrobial Resistance in Gram-positive Bacterial Infections

Ibezapolstat has previously received FDA QIDP and Fast-Track Designation


STATEN ISLAND, N.Y., Oct. 19, 2023 /PRNewswire/ -- Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) ("Acurx" or the "Company"), a clinical stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, today announced three scientific posters were presented during the 13th International Conference on Molecular Biology and Pathogenesis of Clostridia (ClostPath) held in Banff, Canada from September 19 to 23, 2023. Additionally, two podium presentations were made at the Infectious Disease Society of America (IDSA) IDWeek™ 2023 Conference held October 11-15, 2023 in Boston, MA. Highlights of each are shown below.

Robert J. DeLuccia, Executive Chairman of Acurx, stated: "In light of our recent decision to discontinue the Phase 2b ibezapolstat clinical trial earlier than planned and prepare for Phase 3 clinical trials, the new information contained in these scientific posters and presentations at these conferences will add to our evidence-based briefing package for an End of Phase 2 FDA meeting planned for in the first half of next year." He also added: "We are currently compiling and verifying all data from the Phase 2b trial and we will report topline clinical efficacy for the primary clinical endpoint and safety data in the coming weeks, with other outcome data available later this year".

ClostPath:

Ibezapolstat modulates Clostridioides difficile virulence factors in vitro

Presented by Eugenie Basseres, et al; University of Houston College of Pharmacy


Ibezapolstat reduces toxin production by C. difficile

C. difficile In Vitro Biofilm Studies of Ibezapolstat And Comparator Antibiotics

Presented by M. Jahangir Alam et al; University of Houston College of Pharmacy


Ibezapolstat was as effective as the currently-used anti-C. difficile agents fidaxomicin, vancomycin and metronidazole to reduce biofilm-embedded C. difficile quantity and biofilm biomass

Metagenomic Evaluation of Ibezapolstat Compared to Other Anti-Clostridioides difficile Agents

Presented by Jinhee Jo, University of Houston College of Pharmacy


Ibezapolstat and fidaxomicin caused proportional increases in Bacteroidetes distinct from vancomycin and metronidazole, which caused proportional increases in Proteobacteria

IDWeek:

First of a New Class of Antibiotics (pol IIIC Inhibitors) Targeting CDC/FDA/WHO Priority Pathogens

Presented by Michael Silverman, MD, FACP, Acurx's Medical Director; at the New Antimicrobials in the Pipeline session


Among the promising data for ibezapolstat in the treatment of C. difficile are in vitro potency, anti-virulence activities, high human fecal concentrations, 100% Clinical Cure rate in a 10-patient open-label trial, favorable safety profile to date, and potentially beneficial effects on the gut microbiome

Elucidating the Gram-Positive Selective Spectrum Activity of Ibezapolstat; Secondary Analysis from the Phase 2a trial; Presented by Kevin Garey, PharmD, MS, Professor& Chair, University of Houston, School of Pharmacy

Ibezapolstat showed variable selectivity against Firmicutes helping to elucidate its narrow spectrum of activity against certain pathogenic Firmicutes including C. difficile

The posters and presentations are available on the Company's website www.acurxpharma.com.


About Ibezapolstat

Ibezapolstat is a novel, orally administered antibiotic being developed as a Gram-Positive Selective Spectrum (GPSS™) antibacterial. It is the first of a new class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections. Ibezapolstat's unique spectrum of activity, which includes C. difficile but spares other Firmicutes and the important Actinobacteria phyla, appears to contribute to the maintenance of a healthy gut microbiome.

In June 2018, ibezapolstat was designated by the U.S. Food and Drug Administration (FDA) as a Qualified Infectious Disease Product (QIDP) for the treatment of patients with CDI and will be eligible to benefit from the incentives for the development of new antibiotics established under the Generating New Antibiotic Incentives Now (GAIN) Act. In January 2019, FDA granted "Fast Track" designation to ibezapolstat for the treatment of patients with CDI. The CDC has designated C. difficile as an urgent threat highlighting the need for new antibiotics to treat CDI.

About the Ibezapolstat Phase 2 Clinical Trial

The completed multicenter, open-label single-arm segment (Phase 2a) study was followed by a double-blind, randomized, active-controlled, non-inferiority, segment (Phase 2b) at 28 US clinical trial sites which together comprise the Phase 2 clinical trial (see https://clinicaltrials.gov/ct2/show/NCT04247542). This Phase 2 clinical trial was designed to evaluate the clinical efficacy of ibezapolstat in the treatment of CDI including pharmacokinetics and microbiome changes from baseline and continue to test for anti-recurrence microbiome properties seen in the Phase 2a trial, including the treatment-related changes in alpha diversity and bacterial abundance and effects on bile acid metabolism.

The completed Phase 2a segment of this trial was an open label cohort of up to 20 subjects from study centers in the United States. In this cohort, 10 patients with diarrhea caused by C. difficile were treated with ibezapolstat 450 mg orally, twice daily for 10 days. All patients were followed for recurrence for 28± 2 days. Per protocol, after 10 patients of the projected 20 Phase 2a patients completed treatment (100% cured infection at End of Treatment), the Trial Oversight Committee assessed the safety and tolerability and made its recommendation regarding early termination of the Phase 2a study and advancement to the Ph2b segment.

The Phase 2b clinical trial segment has been discontinued due to success. The Company made this decision in consultation with its medical and scientific advisors and statisticians based on observed aggregate blinded data and other factors, including the cost to maintain clinical trial sites and slow enrollment due to COVID-19. The Company has determined that the trial performed as anticipated for both treatments, ibezapolstat and the control antibiotic vancomycin (a standard of care to treat patients with CDI), with high rates of clinical cure observed across the trial without any emerging safety concerns. Accordingly, an Independent Data Monitoring Committee will not be required to perform an interim analysis of this Phase 2b trial data as originally planned. Acurx will analyze the data and report topline efficacy results promptly. The Company anticipates that this decision will allow the Company to advance this first-in-class, FDA QIDP/Fast Track-designated antibiotic product candidate to Phase 3 clinical trials more expeditiously.

In the now completed Phase 2b trial segment, 32 patients with CDI were enrolled and randomized in a 1:1 ratio to either ibezapolstat 450 mg every 12 hours or vancomycin 125 mg orally every 6 hours, in each case, for 10 days and followed for 28 ± 2 days following the end of treatment for recurrence of CDI. The two treatments were identical in appearance, dosing times, and number of capsules administered to maintain the blind.

This Phase 2 clinical trial will also evaluate pharmacokinetics (PK) and microbiome changes and test for anti-recurrence microbiome properties, including the change from baseline in alpha diversity and bacterial abundance, especially overgrowth of healthy gut microbiota Actinobacteria and Firmicute phylum species during and after therapy. In the event noninferiority of ibezapolstat to vancomycin is demonstrated, further analysis will be conducted to test for superiority. Phase 2a data demonstrated complete eradication of colonic C. difficile by day three of treatment with ibezapolstat as well as the observed overgrowth of healthy gut microbiota, Actinobacteria and Firmicute phyla species, during and after therapy. Very importantly, emerging data show an increased concentration of secondary bile acids during and following ibezapolstat therapy which is known to correlate with colonization resistance against C. difficile. A decrease in primary bile acids and the favorable increase in the ratio of secondary-to-primary bile acids suggest that ibezapolstat may reduce the likelihood of CDI recurrence when compared to vancomycin.

About ClostPath

The ClostPath conferences, which began in 1995, have been a leading venue to bring together top scientists and clinicians studying the molecular biology of clostridia and their role in health and disease. The scientific program of ClostPath 13 included lectures by internationally recognized leaders in clostridial research and clinical practice. In addition to state-of-the-art invited talks on the most recent and exciting discoveries in the field, short oral contributions were selected from submitted abstracts. Poster presentations gave attendees the opportunity to discuss their ongoing work with a broad audience in line with the goal to bring together basic science with clinical and translational research issues.

About the IDSA and IDWeek

The Infectious Diseases Society of America (IDSA) is a community of over 12,000 physicians, scientists and public health experts who specialize in infectious diseases. Our mission is to improve the health of individuals, communities, and society by promoting excellence in patient care, education, research, public health, and prevention relating to infectious diseases. IDWeek is the joint annual meeting of the Infectious Diseases Society of America (IDSA), Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA), the Pediatric Infectious Diseases Society (PIDS), and the Society of Infectious Diseases Pharmacists (SIDP). Over 9,500 participants attended this conference in October 2022.

About Clostridioides difficile Infection (CDI). According to the 2017 Update (published February 2018) of the Clinical Practice Guidelines for C. difficile Infection by the Infectious Diseases Society of America (IDSA) and Society or Healthcare Epidemiology of America (SHEA), CDI remains a significant medical problem in hospitals, in long-term care facilities and in the community. C. difficile is one of the most common causes of health care- associated infections in U.S. hospitals (Lessa, et al, 2015, New England Journal of Medicine). Recent estimates suggest C. difficile approaches 500,000 infections annually in the U.S. and is associated with approximately 20,000 deaths annually. (Guh, 2020, New England Journal of Medicine). Based on internal estimates, the recurrence rate of two of the three antibiotics currently used to treat CDI is between 20% and 40% among approximately 150,000 patients treated. We believe the annual incidence of CDI in the U.S. approaches 600,000 infections and a mortality rate of approximately 9.3%.

About the Microbiome in Clostridioides difficile Infection (CDI) and Bile Acid Metabolism

C. difficile can be a normal component of the healthy gut microbiome, but when the microbiome is thrown out of balance, the C. difficile can thrive and cause an infection. After colonization with C. difficile, the organism produces and releases the main virulence factors, the two large clostridial toxins A (TcdA) and B (TcdB). (Kachrimanidou, Microorganisms 2020, 8, 200; doi:10.3390/microorganisms8020200.) TcdA and TcdB are exotoxins that bind to human intestinal epithelial cells and are responsible for inflammation, fluid and mucous secretion, as well as damage to the intestinal mucosa.

Bile acids perform many functional roles in the GI tract, with one of the most important being maintenance of a healthy microbiome by inhibiting C. difficile growth. Primary bile acids, which are secreted by the liver into the intestines, promote germination of C. difficile spores and thereby increase the risk of recurrent CDI after successful treatment of an initial episode. On the other hand, secondary bile acids, which are produced by normal gut microbiota through metabolism of primary bile acids, do not induce C. difficile sporulation and therefore protect against recurrent disease. Since ibezapolstat treatment leads to minimal disruption of the gut microbiome, bacterial production of secondary bile acids continues which may contribute to an anti-recurrence effect. Beneficial effects of bile acids include a decrease in primary bile acids and an increase in secondary bile acids in patients with CDI, which was observed in the Company's Ph2a trial results and previously reported. (CID, 2022)

About Acurx Pharmaceuticals, Inc.

Acurx Pharmaceuticals is a clinical stage biopharmaceutical company focused on developing new antibiotics for difficult to treat infections. The Company's approach is to develop antibiotic candidates that target the DNA polymerase IIIC enzyme and its R&D pipeline includes antibiotic product candidates that target Gram-positive bacteria, including Clostridioides difficile, methicillin-resistant Staphylococcus aureus (MRSA), vancomycin resistant Enterococcus (VRE) and drug-resistant Streptococcus pneumoniae (DRSP).

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[Squeejo]

We’ll that sure is ugly

[Squeejo]

Thanks , next couple of weeks should be interesting.

[gfp927z]

That sounds about right imo. $750 mil would be a 10 bagger from here, $525 mil a 7 bagger. That shows just how undervalued the stock is, even after the recent rebound. The key to stopping C. Dif is for the patient to maintain and restore their normal gut microbiome, which is what occurs with ACXP's approach. Vancomycin kills the C. Dif, but simultaneously wipes out the entire normal gut flora, leading to reinfection / recurrence. There are never any guarantees in biotech, but ACXP looks like the best odds you are likely to see in the sector, imo.



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[Jeff4iam4]

The speculation based on Luci’s (company President) past buyouts for other companies he has been involved in, ACXP would likely be bought for about $750 million. Personally I see it going for anywhere between $450 million and $700 million if the sell now, with a likely price of at least $600 million. He has been talking with several prospective buyers and has been vocal that he would rather sell, but would be fine with a partnership. There is also a possibility of the Pasture Act being passed which would be very lucrative for the company…but Congress is slow, especially now. My guess is 64% chance he sells, 35% chance we partner with large pharmaceutical and 1% chance he waits for Pasture Act to pass. 0% chance he goes to Phase 3 without one of the three above.

[gfp927z]

>> price tag <<

I figure it should be a big number, considering that ACXP's drug will likely become the new standard treatment for C. Dif, and the market is so huge --> 500,000 cases of C. Dif in the US per year, and 20,000 deaths. So the acquisition price tag can be many multiples of ACXP's current $75 mil market cap. We should get the full unblinded Phase 2b details soon, although we already know that clinically the results were excellent. While the bio sector is full of surprises, logic says that ACXP should be a big winner, so we'll see what happens :o)



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[Squeejo]

Any guess as to what price tag they would have on the company?
In the presentation he said they were actively seeking buyers.
Sure would be a major boost if congress could get their act together and pass the pasture act.

[gfp927z]

Yes, looking good, and starting to get on people's radar. The CEO has said that he wants the company to be acquired by a larger pharma prior to the Phase 3. The full unblinded Phase 2b results should be coming out within the next several weeks,

The lack of recurrence / reinfection is what will make this the new gold standard for C. Dif. Vancomycin is a broad spectrum antibiotic, and basically zaps the entire intestinal microbiome, leading to C. Dif recurrence. ACXP's drug has a narrow spectrum, and kills the C. Dif while leaving the rest of the microbiome intact. This is going to be the new standard treatment for C. Dif.



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[Squeejo]

ACXP is the gift that keeps on giving.

[gfp927z]

Acurx CEO presentation from earlier in the year. This provides an excellent overview -

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[Squeejo]

Still in the green for the day . Amazing!

[Monksdream]

ACXP new 52 week high

[Pt3]

What pnd

[TrendTrade2016]

Monster bio

[Triple nickle]

In the fives I’m real good

[Pt3]

Load now trapped above 8

[Triple nickle]

Loaded the boat and smackin the ask

[Triple nickle]

Boom baby

[Squeejo]

Maxim raises price target from 7 to 10 dollars!!

[Squeejo]

Anyone have an idea how long it will be before we get the data from the 2b?

[TrendTrade2016]

We find them early. Harder you work the better the plays you find

[Squeejo]

Agree 100% we are just getting started here!!

[Jeff4iam4]

It is just getting started. When data results from their 2b trial are published the whole market will notice and then you will see a rise that makes the one today look like a small blip on a radar screen. And a buyout shortly after is highly likely based on statements the CEO made recently. He is well known for completing buyouts for huge profit…almost every time.

[Squeejo]

Beast and a lot of room to run!!!

[TrendTrade2016]

ACXP...MONSTER

[TrendTrade2016]

ACXP.. TRIGGER HIT 2.29

[TrendTrade2016]

ACXP, TRIGGER 2.29 COMING IN

[TrendTrade2016]

ACXP..BEAUTY BOTTOM BIO BEAST

[TrendTrade2016]

ACXP...NEXT BIO BEAST TO GO!!!