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.