Innovation Pharmaceuticals Inc (IPIX)

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Exciting "news": Brilacidin already Phase II successful

First my apologies to longtime investors in IPIX who already knew all this, and much respect to some of you here who have been invested for a long time, as I learned from reading many of today's posts.
For newer shareholders, myself included, this is probably going to be interesting. In digging into the history of Brilacidin and its birth origin in a University of Pennsylvania science community biotech startup, PolyMedix, which Leo Erlach of Innovation (then Cellceutix) ended up buying for what Leo admitted then was an incredible bargain price of $2.1 million when PolyMedix was in bankruptcy court.

Enjoyed reading this oldie but goodie article. "SAFE and EFFECTIVE," Brilacidin was overdue for an FDA approval even before Covid happened, and I'm confident we'll be hearing it's highly effective and safe to use vs. CV-19 for the hospitalized clinic participants this week, as well!

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PolyMedix Announces Positive Results From Phase 2 Clinical Trial With PMX-30063 First-in-Class Defensin-Mimetic Antibiotic
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April 23, 2012 07:00 ET | Source: PolyMedix, Inc.
Study in patients with Acute Bacterial Skin and Skin Structure Infections showed all three doses to have high clinical response rates and to be safe

Conference Call Today at 9:00 a.m. ET

RADNOR, Pa., April 23, 2012 (GLOBE NEWSWIRE) -- PolyMedix, Inc. (OTCBB:PYMX), a biotechnology company focused on developing innovative therapeutic drugs to treat patients with serious acute-care conditions, today announced positive topline results from a Phase 2 proof-of-concept study evaluating PMX-30063, a first-in-class investigational antibiotic, for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by Staph aureus. The study objectives were met, demonstrating clinical efficacy and safety in all evaluated doses of PMX-30063.

"I am very encouraged by the final results seen in our first Phase 2 study," said Daniel Jorgensen, MD, MPH, Senior Vice President Clinical Development and Chief Medical Officer of PolyMedix. "These results are particularly exciting, as PMX-30063 is the first of a new class of antibiotics that imitates the body's own immune system and its ability to fight off bacteria. This study demonstrates clinical response rates that are early, sustained, and consistent across all treatment groups. In our next clinical trial, planned for later this year, we will explore ways to optimize the dosing regimen, which will include shorter courses of therapy and the administration of PMX-30063 as a single dose."

Study Details and Results

The randomized, double-blinded and controlled study evaluated the effects of PMX-30063 compared with an active control, daptomycin, for the treatment of Acute Bacterial Skin and Skin Structure Infections. The study followed the most recent Guidance issued by the Food and Drug Administration (FDA), and was conducted at 21 sites in Canada, Russia and Ukraine. The trial enrolled a total of 215 patients across four dosing arms. Three arms were administered low, medium, or high doses of PMX-30063 (0.4 mg/kg on day one followed by 0.30 mg/kg daily for four days; 0.75 mg/kg on day one followed by 0.35 mg/kg daily for four days; or 1.0 mg/kg on day one followed by 0.35 mg/kg daily for four days) plus two days of placebo for a total of seven days. The fourth arm was administered daptomycin daily for seven days (per label recommendations).

Efficacy

In the study, patients were first evaluated at day 3 for clinical response using FDA's most recent ABSSSI Guidance. As summarized in the following table, patients receiving low, medium, or high doses of PMX-30063 experienced high clinical response rates at Day 3.

Clinical Response at Day 3 Low Dose Med Dose High Dose Daptomycin
Per Protocol1 85.0% 71.4% 89.7% 74.5%
mITT2 81.4% 67.6% 77.8% 74.5%
ITT3 79.6% 68.5% 75.9% 75.5%

1 - Per Protocol Population: All patients who received ≥ 80% of study drug, were culture confirmed for Staph aureus, and were assessed (N=161)
2 - mITT (modified Intent-to-Treat) Population: All patients with culture-confirmed Staph aureus (N=172)
3 - ITT (Intent-to-Treat) Population: All patients who were randomized into the study (N=215)
All regimens of PMX-30063 for all patient populations and time points showed early, high and sustained clinical responses. The 95% confidence intervals for the day 7, 10 and 28 assessments, shown in the graphs below, illustrate the consistency of clinical responses for all dosing arms of PMX-30063 compared to active control.

Graphs accompanying this release are available at https://media.globenewswire.com/cache/16232/file/13428.pdf

The early, high, and consistent clinical response rates across the three PMX-30063 dose groups observed in the study suggest the potential for exploration of shorter treatment regimens, which may include study of single dose administration in our next study planned to commence later this year.

"Because of increasing bacterial drug resistance, infectious diseases have become one of the leading causes of death, and are a significant medical, societal, and economic problem," commented Nicholas Landekic, President and Chief Executive Officer of PolyMedix. "Most antibiotics fall within classes for which resistant bacterial strains have already emerged, and there is an urgent need for new approaches. PMX-30063 is the very first defensin-mimetic in clinical trials, and has a mechanism of action specifically designed to address this growing problem, and to which bacterial resistance should be unlikely to develop. We are proud to be pioneers in this field and look forward to progressing the development of PMX-30063."

Safety

In the study, PMX-30063 appeared to be safe and was generally well-tolerated. As expected and consistent with previous clinical studies, patients receiving PMX-30063 commonly reported sensations of numbness and tingling that were generally characterized as mild and resolved following treatment. No patient stopped treatment as a result of these sensations.

About PMX-30063

PolyMedix's novel antibiotic compound, PMX-30063, is the first of a new class of antibiotics — defensin-mimetics. PMX-30063 is a small-molecule designed to mimic the activity of human host-defense proteins (HDPs), the body's natural defense against bacterial infections. HDPs kill bacteria by directly targeting bacterial membranes and disrupting them. Widespread resistance to this mechanism of action has not developed despite millions of years of evolution. With PMX-30063 designed to mimic HDPs, we believe that resistance is also unlikely to evolve to this novel antibiotic compound, making PMX-30063 a potential solution to the growing problem of bacterial resistance.

About PolyMedix, Inc.

PolyMedix is a clinical stage biotechnology company developing first-in-class, small-molecule drugs for the treatment of serious acute care conditions. PolyMedix has two lead compounds and a pipeline of innovative infectious disease and cardiovascular product candidates, all of which were internally developed using a proprietary drug discovery technology platform.

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If newbies are wondering if PMX-30063 = Brilacidin, the answer is yes.

(RADNOR, Pa., June 12, 2012 (GLOBE NEWSWIRE) -- PolyMedix, Inc. (OTCBB:PYMX), a biotechnology company focused on developing innovative therapeutic drugs to treat patients with serious acute-care conditions, today announced that the United States Adopted Names (USAN) Council, in consultation with the World Health Organization (WHO) International Nonproprietary Names Expert Committee, has approved the use of the nonproprietary generic name "brilacidin" (pronounced bri-la-SIGH'-din) for PMX-30063, a first-in-class defensin mimetic antibiotic. PolyMedix recently announced positive results from a Phase 2 clinical study with brilacidin as an intravenous treatment in patients with acute bacterial skin and skin structure Staph aureus infections.

"PMX-30063, now referred to as brilacidin, is the first compound in the new cidin class of antibiotics," commented Nicholas Landekic, President and CEO of PolyMedix. "The cidins are unlike any other class of systemic antibiotic approved or in development. They imitate how our body's own immune system combats bacterial infections. Brilacidin, our lead clinical compound, kills bacteria that are resistant to other antibiotic classes, with a mechanism to which resistance is unlikely to develop.)


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Old news to many long time posters here I am sure. But I found it encouraging to read up on this while waiting along with the rest of you to hear word on Brilacidin's anti-Covid testing and watch as IPIX climbs steadily up the charts.