PolyMedix receives FDA regulatory clearance for PMX-30063 IND application

PolyMedix, Inc. (OTC BB: PYMX), an emerging biotechnology company focused on developing new therapeutic drugs to treat infectious diseases and acute cardiovascular disorders, has received regulatory clearance from the United States Food and Drug Administration (FDA) for its Investigational New Drug (IND) application for PMX-30063, a synthetic defensin-mimetic antibiotic. As the first step in PolyMedix's United States clinical development activities with PMX-30063, PolyMedix has initiated a Phase 1 clinical trial. The trial is designed to further evaluate the safety and pharmacokinetic profile of PMX-30063 in female subjects, who have not been previously studied in Phase 1 trials, as well as male subjects, over a longer term treatment regimen. PolyMedix is currently conducting a Phase 2 clinical trial in Canada to evaluate the safety and efficacy of PMX-30063 in patients as an initial treatment for Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by Staph bacteria.

“We appreciate the feedback from the FDA and are extremely pleased to receive regulatory clearance to initiate clinical development in the United States for PMX-30063”

"We appreciate the feedback from the FDA and are extremely pleased to receive regulatory clearance to initiate clinical development in the United States for PMX-30063," commented Nicholas Landekic, President and CEO of PolyMedix. "We continue to be encouraged by the data generated to-date with PMX-30063, and are proud to be developing the first of a new class of antibiotics. PMX-30063 is the first and only systemic small-molecule antibiotic in clinical development specifically designed to mimic the activity of human host defense proteins, a mechanism of action that we believe reduces the risk of bacterial resistance."

This randomized, double-blind, multiple-dose Phase 1 study will be conducted at a single site in the United States. Twenty subjects will be enrolled into two gender cohorts and randomized to receive either PMX-30063 or placebo. The study will evaluate the safety and pharmacokinetics of PMX-30063 administered at the highest currently anticipated therapeutic loading dose regimen, given over a longer period than has previously been studied. Upon successful completion of this study, PolyMedix intends to have discussions with the FDA regarding further development of PMX-30063 in the United States.

In September 2010, PolyMedix initiated a Phase 2 clinical trial in Canada to evaluate the safety and efficacy of PMX-30063 in patients as an initial treatment for ABSSSI caused by Staph. Results from two Phase 1 studies in Canada demonstrated that PMX-30063 could be safely administered in single or divided intravenous doses, at levels that exceeded theoretical efficacious levels predicted by animal models. In addition, PMX-30063 killed Staph bacteria, including MRSA, in human serum in blood samples drawn from subjects in the study.