Acurx CEO: FDA Opens Potential Faster Path for New C. Diff Antibiotic

Acurx Pharmaceuticals CEO David Luci discusses the company’s recent Type C meeting with the FDA and what it could mean for the development of its C. difficile antibiotic program. According to Luci, the FDA indicated it may be open to considering approval for acute C. difficile infection based on one Phase 3 trial rather than the generally required two, provided the company produces sufficiently robust efficacy data. Acurx is also preparing a 20-patient study in recurrent C. diff as it works toward potentially treating the infection while preventing recurrence.

Luci explains the scale of the opportunity, citing approximately 500,000 U.S. C. diff cases and 30,000 deaths annually, with Acurx targeting a market he estimates at more than $1 billion. He also discusses the company’s cash position and potential M&A opportunities, its research partnership with Leiden University Medical Center, and how AI is being used in the development of a new class of antibiotics and potentially accelerating future drug discovery.

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