Efficacy and Safety Demonstrated in All Evaluated Dose Groups
First Clinical Study with New Class of Antibiotic in Patients with S. aureus ABSSSI Infections
Conference Call Today at 9:00 am ET
RADNOR, Pa., Dec. 7, 2011 (GLOBE NEWSWIRE) -- PolyMedix, Inc. (OTCBB:PYMX), a biotechnology company focused on developing new therapeutic drugs to treat life-threatening infectious diseases and acute cardiovascular disorders, announced that an interim analysis of results from more than 80 patients enrolled in its Phase 2 clinical trial with PMX-30063 defensin-mimetic antibiotic, indicate that all dosing arms in the study were both safe and effective in treating patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by S. aureus. This is the first ever patient clinical efficacy study conducted with this new defensin-mimetic antibiotic class. PolyMedix is continuing to enroll patients and expects to complete the full trial in the first half of 2012.
Combined results from all patients enrolled in the four dosing arms showed:
- A combined clinical cure rate of 92%, with each of the four dosing arms (approximately 20 patients in each arm) having clinical cure rates ranging from 87% to 100%. Evidence of an early and sustained clinical cure is expected to be the primary endpoint for future Phase 3 pivotal trials for ABSSSI.
- Efficacy and safety support continued dosing for all study arms.
- All dose groups were safe and generally well-tolerated with no clinically significant differences observed between the groups.
Dr. Daniel Jorgensen, Chief Medical Officer of PolyMedix commented, "Observations to date from the interim analysis suggest that all three dosing regimens of PMX-30063 are effective and safe in treating patients with ABSSSI S. aureus infections. We are encouraged with the observations from this study, especially the minimal differences between dosing arms, which allowed for data analysis without unblinding the dose groups. With signs of all dosing arms working, we believe PMX-30063 could potentially have a very attractive therapeutic window and may warrant the evaluation of shorter treatment regimens in the future."
"PMX-30063 is the first, and to date only, compound in this new class of defensin-mimetic antibiotics that we are very proud to have discovered," said Nicholas Landekic, President and Chief Executive Officer of PolyMedix. "Unlike currently marketed antibiotics, our defensin-mimetic antibiotics are designed to kill bacteria utilizing a mechanism of action that is likely to evade bacterial resistance. These results are the first ever efficacy observations with a defensin-mimetic antibiotic and represent an important milestone for PolyMedix and the ongoing clinical development of PMX-30063 in its first indication for ABSSSI."
The multinational Phase 2 clinical trial is designed to evaluate the safety and efficacy of PMX-30063 in treating patients with ABSSSI due to either methicillin-susceptible (MSSA) or methicillin-resistant (MRSA) S. aureus. Up to 200 patients will be enrolled and randomized to receive either one of three 5-day dose regimens of PMX-30063 or daptomycin's approved 7-day dose regimen, which is the active control. Patients receiving PMX-30063 are being treated for 5 days and assessed for clinical and microbiologic response while on therapy (Day 3) and at the end of therapy (Day 7). Patients are then re-evaluated at day 10 to 15 for test of cure and at 4 weeks for safety follow up. This trial design incorporates the clinical assessments outlined in the most recent FDA Draft Guidance for ABSSSI.
Conference Call Details
PolyMedix is hosting a conference call today at 9:00 am Eastern Time. Participants may access this audio webcast through a live broadcast on the Company's website at www.polymedix.com or http://www.investors.polymedix.com/eventdetail.cfm?eventid=106055.
Participants should log onto the audio webcast at least 15 minutes prior to the call. The Internet presentation will be available for up to 90 days after the call at the Company's website.
The call in number is 877-771-7024. The international call in number is 678-905-9379. A replay of the conference call will be available two hours after the call's completion and remain available for seven days. The replay number to hear the conference call is 855-859-2056 or 404-537-3406. The passcode is 30580442.
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, making PMX-30063 a potential solution to the growing problem of bacterial resistance. PMX-30063 has been tested in three Phase 1 clinical studies and is currently in a Phase 2 clinical trial to treat patients with Acute Bacterial Skin and Skin Structure Infections caused by S. aureus bacteria.
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 a pipeline of novel infectious disease and cardiovascular product candidates, all of which were internally developed using a proprietary drug discovery platform. PolyMedix's infectious disease program is centered on developing a new class of antibiotic's, known as defensin-mimetics, which are designed to mimic first-line human innate immunity, or host defense proteins. This innovative approach utilizes the same mechanism of action that evolved in nature which higher life forms use to protect themselves from bacteria. Having the same mechanism of action as the host defense proteins, defensin-mimetic antibiotics are designed to directly address one of the most significant issues in infectious disease today, drug resistance, which is believed to be much less likely to develop with this new defensin-mimetic class. PolyMedix's lead defensin mimetic drug candidate, PMX-30063, is currently in a Phase 2 clinical trial for its initial indication to treat patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by S. aureus bacteria, including methicillin-resistant S. aureus (MRSA). PolyMedix is also leveraging its antimicrobial expertise with the PolyCides®, antimicrobial additives to materials, such as cosmetics, plastics and textiles, to create self-sterilizing products and surfaces. The lead compound in PolyMedix's cardiovascular program is PMX-60056, which is designed to restore coagulation and mitigate bleeding in certain interventional cardiology procedures as well as treat bleeding in emergency situations where heparin and low molecular weight heparins (LMWHs) are used. PMX-60056 has met safety and efficacy endpoints in four clinical trials conducted to date demonstrating clinical proof of concept. PMX-60056 is currently in a Phase 2 clinical trial in patients undergoing PCI and in a Phase 1B/2 dose ranging clinical trial in subjects receiving the LMWH enoxaparin. For more information, please visit our website at www.polymedix.com.
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This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause PolyMedix's actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. PolyMedix has in some cases identified forward-looking statements by using words such as "anticipates," "believes," "hopes," "estimates," "looks," "expects," "plans," "intends," "goal," "potential," "may," "suggest," and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are PolyMedix's need for, and the availability of, substantial capital in the future to fund its operations and research and development, and the fact that PolyMedix's compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in PolyMedix's filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. PolyMedix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.