PolyMedix Completes Enrollment in Phase 2 Trial With PMX-30063 Defensin-Mimetic Antibiotic
Phase 2 Final Results Expected in 1H 2012
RADNOR, Pa., Jan. 4, 2012 (GLOBE NEWSWIRE) -- PolyMedix, Inc. (OTCBB:PYMX), a biotechnology company focused on developing innovative therapeutic drugs to treat serious acute-care conditions, announced that it has completed enrollment of 215 patients in its multinational Phase 2 clinical trial designed to evaluate PMX-30063 defensin-mimetic antibiotic in treating patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by Staphylococcus aureus, including methicillin-resistant Staph aureus (MRSA). This is the first clinical efficacy study conducted in patients with this new defensin-mimetic antibiotic class. In December 2011, PolyMedix reported encouraging efficacy and safety data from an interim analysis of this study, and expects to report data from the full study in the first half of 2012.
"Completing enrollment in this study is a key milestone in our development of this novel antibiotic which is designed to directly address the global problem of bacterial drug resistance," commented Nicholas Landekic, President and Chief Executive Officer of PolyMedix. "We are gratified to have completed enrollment so soon after the encouraging interim efficacy and safety results last month. I would like to thank our enthusiastic investigators and our dedicated clinical team for their efforts in achieving this important milestone. We look forward to analyzing the final results of the study and sharing the outcomes in the first half of this year."
In December 2011, PolyMedix announced interim analysis of results from the first 80 patients enrolled in this Phase 2 clinical trial with PMX-30063. Pooled blinded results from all patients enrolled in the four dosing arms showed a combined clinical success rate of 92%, with each of the four dosing arms (approximately 20 patients in each arm) having clinical success rates ranging from 87% to 100%. In addition, all dose groups were safe with no clinically important differences observed between the groups.
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 innovative antibiotic, making PMX-30063 a novel potential solution to the growing problem of bacterial resistance. PMX-30063 has been successfully tested in three Phase 1 clinical studies and has now completed enrollment in a Phase 2 clinical trial to treat patients with Acute Bacterial Skin and Skin Structure Infections caused by Staph aureus bacteria. |
