PolyMedix, Inc. (OTC BB: PYMX), an emerging biotechnology company focused on developing new therapeutic drugs to treat life-threatening infectious diseases and acute cardiovascular disorders, presented new clinical and pre-clinical data related to the safety and efficacy of its novel, lead defensin-mimetic antibiotic, PMX-30063. PMX-30063 is currently being studied in a Phase 2 clinical trial in patients for treatment of Acute Bacterial Skin and Skin Structure Infections caused by Staph bacteria. The data were presented in an oral presentation and three poster sessions at the 21 st Annual European Congress of Clinical Microbiology and Infectious Disease (ECCMID) / 27 th Annual International Congress of Chemotherapy (ICC) in Milan, Italy. “These important and encouraging data underscore the overall safety profile of PMX-30063,” commented Dr. Bozena Korczak, Senior Vice President of Clinical Development at PolyMedix. “These data reaffirm that PMX-30063 does not cause nerve damage at the tested doses and indicate that interactions with ion channels are the underlying mechanism of the paraesthesia. Our approach to look at the mechanism of action of potential side effects early in clinical development has been well received by the medical community. These data are reassuring and continue to support both the dosing in our ongoing Phase 2 study as well as future development plans for PMX-30063.” In an oral presentation titled “Investigation of Potential Mechanisms Underlying Transient Paraesthesia Associated with PMX-30063 Administration in Human Subjects,” Dr. Korczak presented results from in vivo and in vitro studies to further evaluate the safety profile of PMX-30063. In previously conducted Phase 1 clinical studies, some subjects that received higher doses or prolonged administration of PMX-30063 reported having mild and transient sensations of numbness and tingling in the lips, face, and fingers (paraesthesia). The new data presented by Dr. Korczak suggest that these neurosensory symptoms appear to be related to temporary interactions with certain specific sodium, potassium, or acid sensing ion channels which are found on peripheral sensory nerve fibers. There are a number of widely used marketed pharmaceutical products which also interact with ion channels and may cause some patients to experience temporary paraesthesia. Dr. Korczak also presented, in oral and poster format, results from PolyMedix’s Phase 1 exposure-escalation study in twenty subjects where a high dose of PMX-30063 was administered for up to fourteen days. Following subjective and objective neurological assessments conducted by the study investigator and a Board-certified neurologist, the most frequently reported side-effect was sensory symptoms of tingling and numbness. All symptoms completely resolved on their own within seven days after discontinuation of administration. These results support the principle that temporary affects on ion channel function in peripheral nerves, and not neurotoxicity, are likely associated with some patients experiencing paraesthesia when receiving higher doses or prolonged administration of PMX-30063.
At the same meeting, in a separate poster presentation, Dr. Korczak presented the full results from PolyMedix’s Phase 1 trial evaluating the tolerability, safety and pharmacokinetics of multi-dose intravenous regimens of PMX-30063. The results show that between 0.1 and 0.3 mg/kg of PMX-30063 can be safely administered daily for five days without adverse effects. In addition, PMX-30063 showed bactericidal activity for four tested MSSA and MRSA strains of Staph bacteria in human serum after a single dose of as low as 0.1 to 0.3 mg/kg.Dr. Korczak also presented research on the in vitro activity profile of PMX-30063 against recently identified clinical isolates of Gram-positive and Gram-negative pathogens. Overall, PMX-30063 was highly potent against Staphylococci and other Gram-positive cocci including beta-hemolytic Streptococci and E. faecium, as well as E. cloacae and Citrobacter species. Importantly, the antimicrobial activity of PMX-30063 was only slightly affected by the presence of human plasma, which is distinct from some other antibiotics where there may be a significant effect of human plasma. All of the presentations can be found on PolyMedix’s website at www.polymedix.com. 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 one potential solution to the growing problem of bacterial resistance. PMX-30063 is currently in a Phase 2 clinical trial to treat patients with Acute Bacterial Skin and Skin Structure Infections caused by Staph bacteria. 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. PolyMedix’s lead antibiotic compound, PMX-30063, is currently in a Phase 2 clinical trial for treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by Staph, including MRSA. PMX-30063 is a small-molecule that mimics the mechanism of action of human host defense proteins, a mechanism that is distinct from currently approved antibiotic drugs and is intended to make bacterial resistance unlikely to develop. PolyMedix’s lead heptagonist compound, PMX-60056, is in a Phase 2 clinical trial in patients undergoing PCI procedures. PMX-60056 is designed to reverse the anticoagulant activity of both heparin and low molecular weight heparins (LMWH). 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 and LMWH. In addition to its small molecule therapeutics, PolyMedix has polymeric formulations with the same mechanism of action as PMX-30063, PolyCides ®. PolyCides are intended for use in antimicrobial biomaterials applications as additives to paints, plastics, and textiles to create self-sterilizing products and surfaces. For more information, please visit our website at www.polymedix.com. 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.