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Hi Mouton - yes I was aware the EPIC-SR results were finally published (failure of the trial as you know was publicized nearly 2 years prior). I alluded to this in my post listing paxlovid as one of the drugs that failed to show a difference in sustained resolution of the 15 symptom endpoints. Japanese regulators allowed Shionogi to focus on fewer endpoints that were more common especially with current variants for approval.
As I said to Vin it could be when data from the SORPIO-HR trial (ensitrelvir) is made public (hopefully it won't be after a 2 year lag like the PFE trial) a cross trial comparison can be made to gauge EDP-235 relative to ensitrelvir on symptom endpoint.
Paxlovid - dewqophile and vinmantoo, I strongly suspect you both know this, but in the Paxlovid EPIC-SR trial reported in NEJM in April, Paxlovid flopped completely on syptom relief. https://www.nejm.org/doi/full/10.1056/NEJMoa2309003
Notwithstanding the "SR" or "standard risk" title, the trial did enroll a significant number of high risk patients if they had been vaccinated. And even in that subgroup, symptoms were not resolved materially sooner:
Sounds like a wonderful trip!
I think the endpoint is resolution of symptoms for one day, and we don't know the difference between placebo and treatment yet
Somewhat agree about virology - the differences could be due to pt populations (notably 30% were high risk vs essentially none in SPRINT), but we just don't know yet without the data. This is more supportive anyway - remdesivir for example was approved without showing any virology effects IIRC
Interestingly Shionogi DID see efficacy on the 14 symptom scale in Asia so they are different patient populations when it comes to immunity
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10858401/#note-ZOI231613-1-s
see table 2 14 symptom scale met stat sig
I don't know if the FDA will be more flexible in light of all these recent failures (add oral remdesivir to the list, paxlovid in standard risk, etc), but usign the 15 symmptom endpoint in a very immune population like we have now is a high bar and I don't know if someone really thinks 235 can clear it - they were 2 days on the 6 most common symptom scale but only a trend I think on the 14 but I don't really recall that data and it was from a smaller study
I think once the actual data are out from scorpio-HR you can try and make some cross trial comparisons
For sure at least some of the 2 billion would eat into Pfizer sales so 2025 paxlovid sales expectations should be revised up IMO
Ensitrelvir suffers from a lot of DDIs too so it wouldn’t have been such a big advance for high risk patients but it could have captured non high risk but now it probably is a stretch to thikk they make it to market at all although let’s see the 6 month long Covid data.
FDA is torpedoing next gen drugs with this strict 15 symptom primary. Japan approved using the most common handful of symptoms which I feel is a very reasonable endpoint (and more in line w flu which required 7 endpoints)
Perhaps the FDA will come around otherwise I’m not sure we are going to get anything other than paxlovid for Covid (and 235 IS an advance when it comes to DDIs but it doesn’t seem like anyone wants to touch it with the 15 symptom endpoint )
I still think this is bullish for enta by dint of a possible stake in paxlovid but the market doesn’t seem to agree
More on Shionogi’s COVID trial:
https://www.fiercepharma.com/pharma/shionogis-homegrown-antiviral-comes-short-global-covid-trial
Notably, the article cites Shionogi’s CEO saying that Xocova could generate $2B of annual sales if approved in the US. It’s unclear how much of this hypothetical sales figure comes from COVID patients who would otherwise have taken Paxlovid vs COVID patients who would otherwise have taken no drug.
Patent Assigned to Enanta Pharmaceuticals, Inc.
Spiropyrrolidine derived antiviral agents
Patent number: 11976084
Abstract: The present invention discloses compounds of Formula (I), and pharmaceutically acceptable salts, thereof: which inhibit coronavirus replication activity. The invention further relates to pharmaceutical compositions comprising a compound of Formula (I) or a pharmaceutically acceptable salt thereof, and methods of treating or preventing a coronavirus infection in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a compound of Formula (I) or a pharmaceutically acceptable salt thereof.
Type: Grant
Filed: November 22, 2021
Date of Patent: May 7, 2024
Assignee: Enanta Pharmaceuticals, Inc.
Inventors: Guoqiang Wang, Ruichao Shen, Jun Ma, Yong He, Xuechao Xing, Hui Cao, Xuri Gao, Xiaowen Peng, Joseph D. Panarese, Yat Sun Or
https://patents.justia.com/assignee/enanta-pharmaceuticals-inc
What are the benefits of pyrrolidine?
Pyrrolidines are very important nitrogen-containing heterocycles. It has glucosidase inhibitory activity, along with antiviral, antibacterial, antidiabetic, and anticancer activities.
Analyst Ed Arce of H.C. Wainwright maintained a Buy rating on Enanta Pharmaceuticals (ENTA – Research Report), reducing the price target to $27.00.
Ed Arce has given his Buy rating due to a combination of factors, including Enanta Pharmaceuticals’ promising developments in its RSV (respiratory syncytial virus) franchise. The anticipation of top-line data readouts from two key Phase 2 studies of their lead RSV program, zelicapavir, in the second half of 2024 is a significant driver. The enrollment progress in these studies, especially with one part fully enrolled and the other advancing, reflects positively on the company’s ability to execute its clinical trials. The high potential of zelicapavir in at-risk populations, including children and adults with RSV complications, underscores the market opportunity for Enanta’s product.
Additionally, the upcoming data from a Phase 2a challenge study of EDP-323, another oral RSV candidate with a different mechanism, enhances the company’s RSV pipeline strength. This candidate’s potential efficacy in combination with other RSV therapeutics offers a strategic advantage. Arce also considers the progress in Enanta’s immunology program, particularly the KIT inhibitor candidate for chronic spontaneous urticaria (CSU), which the company expects to select for clinical development by the fourth quarter of 2024. The innovative approach targeting the depletion of mast cells to treat CSU could address a significant unmet medical need, further justifying the positive outlook on Enanta’s stock.
In another report released today, JMP Securities also reiterated a Buy rating on the stock with a $22.00 price target.
https://www.tipranks.com/news/blurbs/buy-rating-affirmed-for-enanta-pharmaceuticals-amidst-promising-rsv-developments-and-clinical-trial-execution?utm_source=moomoo.com&utm_medium=referral&global_content={%22promote_id%22:13764,%22sub_promote_id%22:57}
Enanta Pharmaceuticals to Participate at the JMP Securities Life Sciences Conference
WATERTOWN, Mass.--(BUSINESS WIRE)--May 7, 2024-- Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for virology and immunology indications, today announced that Jay R. Luly, Ph.D., President and Chief Executive Officer, and Tara L. Kieffer, Ph.D., Chief Product Strategy Officer, will participate in a fireside chat at the JMP Securities Life Sciences Conference on May 14, 2024 at 10:00 a.m. ET in New York, NY.
https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-participate-jmp-securities-life-sciences
ENTA updated corporate slides (5/6/24)
https://ir.enanta.com/static-files/0b9a9564-339c-4501-8c98-eab636846bf4
The latest version of the slide set is almost identical to the previous version (from 3/13/24); the differences are:
• Slides 3 and 7 have updated financial info from FY2Q24 (ending 3/31/24).
• Slide 37, which shows 2024 news flow, has two small changes: 1) Data from the Zelicapavir (f/k/a EDP-938) RSVPEDs study is expected in 2H24 rather than 3Q24; and 2) Selection of a lead candidate in the CSU program is expected in 4Q24 rather than simply 2024. There is no specific guidance on the timing of topline data from the RSVHR study, which is recruiting patients in the Southern Hemisphere.
ENTA reports FY2Q24* results—raises FY2024 expense guidance:
https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-reports-financial-results-its-fiscal-39
• 3/31/24 cash = $300.3M, a decrease of $37M relative to 12/31/23.
• FY2Q24 royalty revenue was $17.1M, -10% QoQ and -4% YoY. 54.5% of ENTA’s Mavyret royalties are payable to OMERS (Canada’s largest pension fund), and this amount is treated for accounting purposes as an amortization of debt (see discussion in #msg-172603887).
• FY2Q24 R&D expenses were $35.6M, consistent with ENTA’s updated fiscal-year guidance of $125-145M (raised from the $100-120M guidance given in Nov 2023).
• FY1Q24 SG&A expenses were $14.2M, consistent with ENTA’s updated guidance of $50-60M (raised from the $45-50M guidance given in Nov 2023). Legal expenses for the Paxlovid lawsuit against PFE were a material portion of the SG&A expenses for the quarter.
• ENTA says its cash and expected royalty revenue are sufficient to fund operations through the end of FY3Q27, which is one quarter earlier than the prior guidance of end of FY2027.
*ENTA’s fiscal year ends on September 30.
correct PFE completed their phase 2 months ago - it is still listed in their pipeline so it has not been formally killed, and data could just be under wraps for competitive reasons
Yeah for a study that most think will be positive I too am starting to think they may have a miss or at least some mixed data. We will probably know more in the coming days w their earnings
The long Covid endpoints are at 24 weeks in the trial listing but they said more than once they plan to unblind data at 12 weeks so??
I concur that Paxlovid 1Q24 sales and 2024 guidance are not surprising; however, I think some investors were confused by PFE's 4Q23 writeoff and didn't realize that the 2023 figure was an accounting artifact rather than a reflection of product demand.
Not sure but I wasn’t surprised by paxlovid sales and think they are lowballing guidance still. They are still the only game in town in western countries although most people think ensitrelvir will be on the market here by early 2025 (although the odds went down a bit IMO when they missed their own guidance for reporting top line data)
Is ENTA getting a delayed bounce from PFE’s $3B 2024 sales guidance for Paxlovid?
This is what Shionogi said on their call Jan 31:
https://www.shionogi.com/content/dam/shionogi/global/investors/ir-library/presentation/2023/3q/e20240202.pdf
“we have completed the enrollment of over 2,000 cases in December 2023. For the primary endpoint, the time to resolution of all COVID-19-related symptoms, all 15 symptoms, was determined after consultation with the FDA.
In addition, we have obtained data on the suppression of the incidence of Long COVID, so-called sequelae, at 12 weeks, and we are verifying this as well in SCORPIO-HR trial. We are keeping the data up to three months under blind, so we expect to be able to present our results to you in April on these results as a topline after a three-month follow-up starting in December.”
April came and went with no PR. You would think an outright hit or miss would be a straightforward readout so perhaps they are doing some post hoc data mining? Could also be they decided to keep the trial blinded out to 24 weeks who knows
Latest Patents Assigned to Enanta Pharmaceuticals, Inc.
Macrocyclic antiviral agents
Patent number: 11970502
Abstract: The present invention discloses macrocyclic compounds of Formula (I), and pharmaceutically acceptable salts, thereof: which inhibit coronavirus replication activity. The invention further relates to pharmaceutical compositions comprising a compound of Formula (I) or a pharmaceutically acceptable salt thereof, and methods of treating or preventing a coronavirus infection in a subject in need thereof, comprising administering to the subject a therapeutically effective amount of a compound of Formula (I) or a pharmaceutically acceptable salt thereof.
Type: Grant
Filed: May 3, 2022
Date of Patent: April 30, 2024
Assignee: Enanta Pharmaceuticals, Inc.
Inventors: Jiajun Zhang, Xiaowen Peng, Yat Sun Or
Bile acid derivatives as FXR/TGR5 agonists and methods of use thereof
Patent number: 11958879
Abstract: The present invention provides compounds represented by Formula I, or pharmaceutically acceptable salts, stereoisomers, solvates, hydrates or combination thereof, The invention also provides pharmaceutical compositions comprising these compounds and methods of using this compounds for treating FXR-mediated or TGR5-mediated diseases or conditions.
Type: Grant
Filed: May 19, 2021
Date of Patent: April 16, 2024
Assignee: Enanta Pharmaceuticals, Inc.
Inventors: Guoqiang Wang, Yat Sun Or, Ruichao Shen, Xuechao Xing, Jiang Long, Peng Dai, Brett Granger, Jing He
https://patents.justia.com/assignee/enanta-pharmaceuticals-inc
Enanta Pharmaceuticals (from X)
Our team presented “Efficacy and Safety of EDP-235 in Non-hospitalized Adults With Mild or Moderate COVID-19: Results From the Phase 2 SPRINT Study” at
@ESCMID Global where it was named a “Top Rated Poster.” Congratulations to the team.
POSTER CONCLUSIONS
• EDP-235 treatment in standard-risk adults with mild or moderate COVID-19 yielded a favorable safety profile and improvements in clinical symptoms
• EDP-235 was generally well tolerated, as reflected by a low frequency of TEAEs that were mostly mild in severity, and there were no serious TEAEs or
TEAE-related discontinuations
• The 400 mg dose of EDP-235 achieved statistically significant improvement in TSS at multiple time points in the overall study population
– In participants enrolled within 3 days of symptom onset, along with significant TSS improvement at all time points, a median 2-day shorter
duration of 6 selected COVID-19 symptoms was observed
• The rapid decline of viral load across all study groups was consistent with an enrolled population that had prior immunity
• The results of the Phase 2 SPRINT study support further development of EDP-235 for the treatment of COVID-19
• As the therapeutic target is conserved across variants, EDP-235 may prove an effective tool to combat future variants of SAR-CoV-2 and potentially
other coronaviruses
Read more:
https://www.enanta.com/wp-content/uploads/2024/04/P0423_ECCMID_2024_SPRINT_Poster_FINAL.pdf
I think maintaining continuity of in-house general counsel would be important during the on-going patent litigation. I also think the experience attained during the term with Enanta would be beneficial to retain during negotiations for Enanta's various technologies -- outsourcing, partnering.
I am quite reasonable and I consider this an untimely and likely disruptive loss which is worthy of acknowledgement thru mention on this board.
The case is farmed out to a high profile MA based firm. The in house counsel is not actively managing the case at all
Even Pfizer uses outside counsel to manage a case like this which requires specific expertise which they simply don't keep in house
Gardiner is 71. I don't see anything odd about his retirement.
Nathaniel Gardiner retired at what could be considered the pinnacle of his career with Enanta, during a high profile lawsuit with Pfizer? Who is your clown?
Enanta Pharmaceuticals Announces the Appointment of Matthew P. Kowalsky as Chief Legal Officer
Apr 30, 2024
“I’m pleased to welcome Matt to Enanta. The breadth of his legal expertise across a wide range of activities in the life sciences industry, including his experience with early and late-stage clinical trials, commercial products, intellectual property, business development and other corporate transactions, makes him an important addition to the Enanta leadership team as we advance toward several important catalysts this year,” commented Jay R. Luly, Ph.D., President and Chief Executive Officer at Enanta Pharmaceuticals. “In addition to his strong expertise and experience, Matt is a proven leader in life sciences, which will support our continued growth as we further our mission of developing important medicines in virology and immunology.”
“I’m proud to join a team with an established track record of success, dedicated to the discovery and development of groundbreaking small molecule drugs in areas of significant unmet medical need,” said Matthew Kowalsky. “With multiple near-term catalysts across the pipeline and a solid cash position, this is an important and transformational time for Enanta. I look forward to collaborating with the seasoned management team to support all initiatives aimed at progressing our pipeline, improving the lives of patients and their caregivers, and enhancing shareholder value.”
https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-announces-appointment-matthew-p-kowalsky
Furthermore -
the Compensation Committee of Enanta Pharmaceuticals’ Board of Directors granted employment inducement awards to Matthew P. Kowalsky, Enanta’s new Chief Legal Officer, consisting of a non-qualified stock option to purchase 150,000 shares of its common stock, performance share units (PSUs) for 4,468 shares of its common stock, and relative total stockholder return units (rTSRUs) for 4,468 shares of its common stock, under the company’s 2024 Inducement Stock Incentive Plan.
The 2024 Inducement Stock Incentive Plan has been adopted by the Board of Directors to be used exclusively for the grant of equity awards to any individual who was not previously an employee or non-employee director of Enanta Pharmaceuticals, as an inducement material to such individual's entering into employment with Enanta Pharmaceuticals, pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules.
Read more:
https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-announces-inducement-grants-under-nasdaq
Enanta Pharmaceuticals to Host Conference Call on May 6 at 4:30 p.m. ET to Discuss its Financial Results for its Fiscal Second Quarter Ended March 31, 2024
Apr 29, 2024
WATERTOWN, Mass.--(BUSINESS WIRE)--Apr. 29, 2024-- Enanta Pharmaceuticals, Inc. (NASDAQ: ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for virology and immunology indications, today announced that it plans to report its financial results for its fiscal second quarter ended March 31, 2024, after the U.S. market closes on May 6, 2024. Enanta management will host a conference call at 4:30 p.m. ET to discuss these results and provide an update on Enanta’s business, including its research and development pipeline.
https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-host-conference-call-may-6-430-pm-et
Media recognition & coverage -
Pharmaceutical Technology -
April 22
Enanta Pharmaceuticals gets grant for inhibiting coronavirus replication with compound of formula
Enanta Pharmaceuticals has been granted a patent for compounds that inhibit coronavirus replication. The patent covers pharmaceutical compositions and methods for treating or preventing coronavirus infections. Formula (I) represents the compound structure.
Excerpts:
Human telomerase RT biomarker was a key innovation area identified from patents.
The patent also covers pharmaceutical compositions containing the compound and a method for treating or preventing coronavirus infections in subjects by administering the compound or a combination of compounds.
....the patent involves administering a therapeutically effective amount of the compound to subjects in need, with specific mention of various types of coronaviruses, including SARS-CoV-2. This patent highlights the potential use of the disclosed compounds in combating coronavirus infections, particularly relevant in the current global health scenario.
https://www.pharmaceutical-technology.com/data-insights/enanta-pharmaceuticals-gets-grant-for-inhibiting-coronavirus-replication-with-compound-of-formula-i-2/?utm_source=lgp6-patents-grant&utm_medium=24-295866&utm_campaign=recommended-articles-pi&cf-view
I never considered a data leak on the RSV drug, but there could be a leak on ensitrelvir data (run by NIH and they have data in hand so could be more leaky than if was strictly managed by shionogi I think) or some happenings in the court case. Most likely of course is that the recent drop is just due to inherent volatility
Right! ENTA updated the guidance for RSVHR reporting on the Leerink webcast on 3/13/24 (the same date as the “new” corporate slide set). The prior “it depends” guidance was from ENTA’s FY1Q24 CC on 2/7/24.
In any event, the salient point is that ENTA is not due to report any clinical data until July at the earliest. This should reassure anyone who may have thought the recent share-price decline was due to a data leak.
ENTA corporate slide set (3/13/24):
https://ir.enanta.com/static-files/0b9a9564-339c-4501-8c98-eab636846bf4
There are no differences between the 3/13/24 slide set and the previous slide set on 2/7/24.
Clinical newsflow reiteration: ENTA expects to report data from the Zelicapavir RSVPEDs trial and the EDP-938 “challenge” trial in 3Q24. ENTA has not yet commented on when it will report data from the Zelicapavir PSVHR trial (for high-risk adults) because that depends on whether enrollment is completed during the current RSV season in the Northern Hemisphere.
Just calling it the way I see it - ENTA does have a potential stake in paxlovid
PFE has been totally silent on their next gen PI for covid - the phase 2 was completed months ago
https://clinicaltrials.gov/study/NCT05799495?term=PF-07817883&rank=5
The market is upset they are allocating the cost of a plane ticket to Spain and hotel for the presentation. It's a few thousand added burn ;)
Joking aside nice to see the data will be presented - it's the right thing to do even on what seems to be a defunct asset
235 could be revived if ensitrelvir doesn't post positive phase 3 data this month. Regardless negative ensitrelvir data would still be bullish for ENTA because it is bullish for paxlovid which would make any potential settlement in the lawsuit more valuable (and vice versa of course if the ensitrelvir data are good)
Capisce?
Everything makes CENTS in a potential takeover. I consider the patent holdings are worth their minimal expense - I.E. the patent infringement suit against PFIZER - if it pans out.
Legal Fees for Patent Applications and Patent Defense
The 8-K shows that patent defense legal fees are assigned to General and Administrative Expenses. Are patent application fees assigned to research and development costs? For years I thought Enanta's patent portfolio was a wonderful asset, but now I am wondering if it was an unscrupulous waste of money transferring oodles of cash from Enanta to their legal counsel. Kickback and enjoy. Capisce?
Patent Assigned to Enanta Pharmaceuticals, Inc.
Bile acid derivatives as FXR/TGR5 agonists and methods of use thereof
Abstract: The present invention provides compounds represented by Formula I, or pharmaceutically acceptable salts, stereoisomers, solvates, hydrates or combination thereof, The invention also provides pharmaceutical compositions comprising these compounds and methods of using this compounds for treating FXR-mediated or TGR5-mediated diseases or conditions.
Type: Grant
Filed: May 19, 2021
Date of Patent: April 16, 2024
https://patents.justia.com/assignee/enanta-pharmaceuticals-inc
In certain embodiments, the FXR-mediated disease or condition is cardiovascular disease, atherosclerosis, arteriosclerosis, hypercholesteremia, or hyperlipidemia chronic liver disease, gastrointestinal disease, renal disease, metabolic disease, cancer (i.e., colorectal cancer), or neurological indications such as stroke.
https://patents.justia.com/patent/11958879
Enanta Pharmaceuticals Announces Data Presentation at ESCMID Global 2024
Apr 17, 2024
WATERTOWN, Mass.--(BUSINESS WIRE)--Apr. 17, 2024-- Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for indications in virology and immunology, today announced that data from the company’s SPRINT (SARS-Cov-2 PRotease INhibitor Treatment) study of EDP-235 has been accepted for a poster presentation at ESCMID Global 2024 (formerly ECCMID) being held April 27–30 in Barcelona, Spain.
The poster presentation includes primary and post-hoc analyses from the double-blind, placebo-controlled Phase 2 clinical trial of EDP-235, a 3CL protease inhibitor, in non-hospitalized, symptomatic adults with mild or moderate COVID-19 who were not at high risk for severe disease.
Poster Title: “Efficacy and Safety of EDP-235 in Non-Hospitalized Adults with Mild or Moderate COVID-19: Results from the Phase 2 SPRINT Study”
Abstract Number: 02980
Poster Number: PO423
Day: April 27, 2024
Time: 12:00 p.m. CEST / 6:00 a.m. ET
Session Location: Poster Area
Session Title: COVID-19 (incl virology, epidemiology, evolution, immune response, diagnosis, treatment, vaccination, prevention, response and societal impact)
Presenter: Scott T. Rottinghaus, M.D., Chief Medical Officer, Enanta Pharmaceuticals, Inc.
The scientific program for ESCMID Global 2024 can be found at https://www.eccmid.org/scientific-programme
https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-announces-data-presentation-escmid-global
one must be able to describe the thinking and process one takes to create that molecule- if one is to defend their IP.
Thanks for your comments re:patents. Seems ENTA is flush with patents protecting their small molecule discoveries. It would make "cents" to have their discoveries certified & protected by their string of patent attorneys. **Pfizer - watch out!
**
I rather enjoy the updates on Enanta's being issued patents.
I long for the day that these will mean something palpable in it's share price.
I hold (or is it merely wishful thinking?) that a company that is centered on discovering molecules MUST have a branch that can rigorously defend those patents, that's skilled at filing patents. It isn't enough to merely create them after, one must be able to describe the thinking and process one takes to create that molecule- if one is to defend their IP.
I say this as Enanta's lawsuit progresses with Pfizer and hope that they have done the work required to successfully defend their IP.
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