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 21st Annual European Congress of Clinical Microbiology and Infectious Disease (ECCMID) / 27th 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.
Source: PolyMedix, Inc.