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.

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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.

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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.

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"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.