PolyMedix, Inc. (OTC BB: PYMX), an emerging biotechnology company focused on developing new therapeutic drugs to treat infectious diseases and acute cardiovascular disorders, today announced the successful completion of a Phase 1 exposure-escalation clinical study with its synthetic defensin-mimetic antibiotic, PMX-30063. The study results showed that PMX-30063 may be safely administered at a high dose for more than five days. These data support dosing levels being studied in the current Phase 2 efficacy study in Staph infections. The results also showed very similar pharmacokinetic profiles of PMX-30063 in male and female subjects.
This randomized, double-blind, placebo-controlled Phase 1 study enrolled twenty male and female subjects at a single site in the United States. Subjects randomized to PMX-30063 received an initial intravenous loading dose of PMX-30063 followed by a daily maintenance dose for up to 14 days. Pharmacokinetic sampling and other neurosensory tests were conducted during treatment and for 30-days thereafter. The doses of PMX-30063 administered were identical to the highest dose regimen currently being administered for five days in PolyMedix’s Phase 2 clinical trial in patients with ABSSSI (Acute Bacterial Skin and Skin Structure Infections) caused by Staphylococcus bacteria, including MRSA.
Similar to results from two previously completed Phase 1 clinical studies with PMX-30063, the most frequently reported side effects included transient sensations of numbness and tingling affecting the lips, face, and fingers (called paraesthesia). These sensations did not worsen over the course of the study and resolved on their own without any treatment shortly after discontinuation of PMX-30063 administration. There were no significant clinical neurosensory abnormalities noted. Only one subject discontinued from the study due to paraesthesia. Several subjects were discontinued by the investigator after receiving between nine and thirteen days of dosing due to increased blood pressure and heart rate, for which there were no associated clinical signs or symptoms. After nine days of dosing, there was one reportable adverse event of atrial fibrillation that was fully reversed within a few hours following dosing. As seen in previous Phase 1 clinical studies, there were a few minor and transient increases in liver enzymes that were not clinically significant. All subjects demonstrated complete return to normal clinical parameters and reported no adverse effects by the time of the last follow up visit. There were no differences in the pharmacokinetics profiles between males and females.