PolyMedix (OTCBB: PYMX) announced topline results from a Phase 2 proof-of-concept study evaluating 
PMX-30063, a first-in-class investigational antibiotic, for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by Staph aureus.
- The study objectives were met, demonstrating clinical efficacy and safety in all evaluated doses of PMX-30063.
- In the study, patients were first evaluated at day 3 for clinical response using FDA's most recent ABSSSI Guidance. Patients receiving low, medium, or high doses of PMX-30063 experienced high clinical response rates at Day 3.
- Clinical Response at Day 3
- Per Protocol: Low Dose 85.0%; Medium Dose 71.4%; High Dose 89.7%; Daptomycin 74.5%
- mITT: Low Dose 81.4%; Medium Dose 67.6%; High Dose 77.8%; Daptomycin 74.5%
- ITT: Low Dose 79.6% Medium Dose 68.5%; High Dose 75.9%; Daptomycin 75.5%
- All regimens of PMX-30063 for all patient populations and time points showed early, high and sustained clinical responses. The 95% confidence intervals for the day 7, 10 and 28 assessments illustrate the consistency of clinical responses for all dosing arms of PMX-30063 compared to active control.
- In the study, PMX-30063 appeared to be safe and was generally well-tolerated. As expected and consistent with previous clinical studies, patients receiving PMX-30063 commonly reported sensations of numbness and tingling that were generally characterized as mild and resolved following treatment. No patient stopped treatment as a result of these sensations. Other treatment-related adverse event rates were similar across all treatment arms.
- There was one treatment-related serious adverse event that was at least possibly drug-related reported in each PMX-30063 study arm. Treatment-related serious adverse events included an instance of hypertension in the medium and high dose regimens, which discontinued therapy, and an instance of increased platelets in the low dose regimen.
- As previously announced, PolyMedix plans to discuss the results of this PMX-30063 Phase 2 clinical trial on its conference call to be held today at 9:00 am Eastern Time and to present study details, including microbiologic data, at a future medical meeting(see linked comment).
