Biopharmaceutical company Acurx Pharmaceuticals Inc (NASDAQ: ACXP) reported on Monday that it has received further FDA guidance on its ibezapolstat clinical development programme, including the potential for a single Phase 3 trial to support a New Drug Application (NDA) for both treatment and reduction of recurrence of Clostridioides difficile infection (CDI).

Following a Type C meeting on 13 July 2026, the FDA agreed that a successful IBZ-ASPIRE Phase 3 trial, supported by the IBZ-PATHFINDER Phase 2 trial in multiply recurrent CDI, could enable an NDA submission covering both indications.

The planned IBZ-ASPIRE trial will evaluate ibezapolstat against vancomycin in approximately 550 patients using a non-inferiority design. If successful, further analyses will assess superiority for reducing recurrence and improving clinical cure rates.

Acurx has initiated start-up activities for the IBZ-PATHFINDER trial in patients with recurrent CDI, with enrolment expected to begin in the coming months. The Company plans to advance the international Phase 3 IBZ-ASPIRE trial subject to funding availability.