PolyMedix has announced the positive data from the Phase 2 proof-of-concept study investigating PMX-30063, a first-in-class investigational antibiotic, used for the treatment of Acute Bacterial Skin and Skin Structure Infections (ABSSSI) caused by Staphylococcus aureus.
PMX-30063 is a small-molecule designed to mimic the activity of human host-defence proteins (HDPs), the body’s natural defence against bacterial infections.
The randomised double-blinded and controlled Phase 2 study was designed to compare the effects of PMX-30063 with an active control daptomycin for the treatment of ABSSSI.
As per Food and Drug Administration (FDA) guidance, the study enrolled a total of 215 patients across four dosing arms, of which three arms were administered low, medium or high doses of PMX-30063 plus two days of placebo for a total of seven days, with the fourth arm being administered daptomycin daily for seven days.
In the study, all regimens of PMX-30063 for all patient populations and time points showed early, high and sustained clinical responses and safety.
PolyMedix chief medical officer and clinical development senior vice president Daniel Jorgensen said that the study demonstrates clinical response rates that are early, sustained, and consistent across all treatment groups.
"In our next clinical trial, planned for later this year, we will explore ways to optimise the dosing regimen, which will include shorter courses of therapy and the administration of PMX-30063 as a single dose," Jorgensen added.
PolyMedix president and chief executive officer Nicholas Landekic said PMX-30063 is the first defensin-mimetic in clinical trials, with a mechanism of action specifically designed to address the growing problem, and to which bacterial resistance should be unlikely to develop.
PolyMedix is a clinical stage biotechnology company developing first-in-class, small-molecule drugs for the treatment of serious acute care conditions.