Acurx Pharmaceuticals (ACXP) Conference presentation summary

Addressing antimicrobial resistance and unmet medical needs

• Focus on developing a new class of antibiotics targeting CDC/FDA/WHO priority Gram-positive pathogens, including C. difficile, MRSA, and VRE.

• DNA pol IIIC inhibitors represent a novel mechanism, with no cross-resistance to existing antibiotics.

• Patented until 2032 with 10 years of regulatory exclusivity from FDA approval.

Clinical development and efficacy of ibezapolstat

• Ibezapolstat demonstrated 100% clinical cure and sustained cure in Phase 2A, and 96.2% in Phase 2B trials for C. difficile infection.

• No recurrence observed; safety profile was favorable with primarily mild GI events.

• Phase 3 trials are ready, with protocols designed for US and EU regulatory submissions.

Microbiome preservation and selectivity

• Ibezapolstat and other pol IIIC inhibitors spare beneficial gut flora, supporting microbiome restoration and reducing recurrence risk.

• Selectivity is explained by unique genomic differences in DNA pol IIIC among gut bacteria.

• Preclinical data suggest microbiome selectivity may be a class effect for pol IIIC inhibitors.