PolyMedix, Inc. Cleared to Run First US Clinical Trial for Antibiotic Inspired by “Defensin Mimetics”

January 13, 2011

As the first step in PolyMedix’s US clinical development activities with PMX-30063, it has initiated a Phase 1 clinical trial.

(Vocus/PRWEB) January 12, 2011

Last November, PolyMedix, Inc., an emerging biotechnology company focused on developing new therapeutic drugs to treat infectious diseases and acute cardiovascular disorders, received regulatory clearance from the FDA to investigate its new antibiotic candidate, PMX-30063.

PMX-30063 was inspired by a key discovery: It is possible to create small molecules that mimic the properties of defensins, the body’s natural host defense proteins. A drug can be designed that punches holes directly in bacterial cell membranes, resulting in the destruction of the genetic machinery often responsible for bacterial resistance and minimizing the chances that such resistance will arise. Biomimetics is the name given to the study of successful strategies adopted by plants and animals, so PMX-30063 is an example of “defensin mimetics.”

As the first step in PolyMedix’s US clinical development activities with PMX-30063, it 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 caused by Staph bacteria.

“We appreciated the feedback from the FDA, and were 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 US.

Last September, 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.

About PMX-30063

PolyMedix’s novel antibiotic compound, 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 unique 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 addition to the alternatives to combat the growing problem of bacterial resistance to currently available antibiotics. There are many forms of Staph bacteria which are antibiotic resistant. Preclinical studies with PMX-30063 have demonstrated bactericidal activity against 181 different drug-resistant forms of Staph bacteria, including those strains resistant to marketed drugs. We believe the activity of PMX-30063 against a broad range of Staph bacteria, including those non-responsive to currently marketed drugs such as vancomycin, daptomycin, and linezolid, distinguishes it among available and investigational antibiotic drugs.

About PolyMedix, Inc.

PolyMedix is a publicly traded biotechnology company focused on the development of novel drugs for the treatment of serious infectious diseases and acute cardiovascular disorders. PolyMedix uses a rational drug design approach to create non-peptide small molecule drug candidates. PMX-30063, PolyMedix’s lead antibiotic compound that is currently in Phase 2 clinical trials, is a small molecule that mimics human host-defense proteins and has a mechanism of action distinct from those of current antibiotic drugs, a mechanism which is intended to make bacterial resistance unlikely to develop. PolyMedix plans to develop this compound for serious systemic Staphylococcal infections, including methicillin resistant Staphylococcus aureus (MRSA). PMX-60056, PolyMedix’s lead heptagonist compound, has completed four clinical trials and is being further developed to reverse the anticoagulant activity of both heparin and low molecular weight heparins. PolyMedix believes that PMX-60056 could potentially be a safer and easier to use anticoagulant reversing agent, with broader activity, than the currently approved therapy for reversing heparin. PolyMedix also plans to continue the development of its PolyCides©, polymeric formulations as antimicrobial biomaterials, which can be used as additives to paints, plastics, and textiles to create self-sterilizing products and surfaces. For more information, please visit our website at http://www.polymedix.com.


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