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news.PolyMedix has received US Food and Drug Administration (FDA) clearence for its investigational new drug (IND) application for PMX-30063, a synthetic defensin-mimetic antibiotic.
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PolyMedix has initiated a Phase 1 clinical trial in US, which is designed to further evaluate the safety and pharmacokinetic profile of PMX-30063 in female subjects, who have not been previously studied in Phase 1 trials, as well as male subjects, over a longer term treatment regimen.
According to the company, approximately 20 subjects will be enrolled into two gender cohorts and randomized to receive either PMX-30063 or placebo.
The study will evaluate the safety and pharmacokinetics of PMX-30063 administered at the highest currently anticipated therapeutic loading dose regimen, given over a longer period than has previously been studied.
Upon successful completion of this study, PolyMedix plans to have discussions with the FDA regarding further development of PMX-30063 in the US.
PolyMedix president and CEO Nicholas Landekic said that they appreciate the feedback from the FDA and are extremely pleased to receive regulatory clearance to initiate clinical development in the US for PMX-30063.
"We continue to be encouraged by the data generated to-date with PMX-30063, and are proud to be developing the first of a new class of antibiotics," Landekic said.
"PMX-30063 is the first and only systemic small-molecule antibiotic in clinical development specifically designed to mimic the activity of human host defense proteins, a mechanism of action that we believe reduces the risk of bacterial resistance."