Acurx Pharma Secures EMA Approval for Ibezapolstat Phase 3 Program

Acurx Pharmaceuticals, Inc., a late-stage biopharmaceutical firm dedicated to creating a novel class of small molecule antibiotics for challenging bacterial infections, announced that it has obtained positive regulatory guidance from the EMA in its Scientific Advice Procedure indicating that the clinical, non-clinical, and CMC (Chemistry Manufacturing and Controls) information package provided supports the progress of the ibezapolstat phase 3 programme.

The informational package backing the phase 3 program contained specifics on Acurx's two intended phase 3 clinical trials (structured as non-inferiority trials compared to vancomycin), the target patient demographic, primary endpoint of Clinical Cure, sample size, statistical analysis strategy, and the comprehensive registration safety database.

Acurx's executive chairman, Bob DeLuccia, stated: "We are appreciative of the EMA's constructive suggestions, and we will proactively incorporate them into our global registration plan. He further stated: "We are very pleased with the latest favourable communications from both regulatory agencies which provide a straightforward international roadmap for conduct of our phase 3 programme and ultimate requirements for a US NDA (New Drug Application) submission and EU Marketing Authorization Application."

Acurx had earlier reported a fruitful end of phase 2 meeting, securing consensus with the FDA on non-clinical and clinical phase 3 readiness, which included written positive remarks on the acceptability of its CMC (Chemistry Manufacturing and Controls) plan and data package suggested to back the phase 3 clinical program.