Acurx’s Ibezapolstat Strengthens Microbiome and Shows Activity Against Anthrax

Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP), a late-stage biopharma company focused on developing new small-molecule antibiotics for hard-to-treat bacterial infections, has shared new analyses extending the positive effects of its antibiotic, ibezapolstat, on gut microbiome health. The data reveal that ibezapolstat increases beneficial bacteria, Actinobacteriota and Bacillota (Firmicutes), reversing dysbiosis and aiding in preventing Clostridioides difficile infection (CDI) recurrence.

The drug's pharmacokinetics were also confirmed, with low systemic exposure (below 1 mcg/mL) and high fecal concentrations that surpass the minimal inhibitory concentration (MIC) for C. difficile. Additionally, microbiological tests on ACX-375, ibezapolstat's DNA polymerase IIIC analogues, showed in vitro efficacy against Bacillus anthracis (Anthrax), including ciprofloxacin-resistant strains, a Category A bioterrorism pathogen.

These findings were presented at the International C. difficile Symposium in Slovenia by Kevin Garey, PharmD, MS, FIDSA, who led the microbiology and microbiome aspects of the ibezapolstat trials. His presentation highlighted a unique microbiome signature found in two vancomycin-treated patients with recurrent CDI in the Phase 2b trial, potentially indicating early prediction of recurrence.

Acurx's Executive Chairman, Robert J. DeLuccia, emphasized ibezapolstat’s distinct product profile, especially the favorable microbiome-related findings. He also noted promising in vitro activity of ibezapolstat against B. anthracis and methicillin-resistant Staphylococcus aureus (MRSA) as the company progresses with its development of treatments for critical gram-positive pathogens.

Acurx recently held a successful FDA End-of-Phase 2 meeting for ibezapolstat and received approval to proceed with Phase 3 trials. Key trial elements, including design, endpoints, and patient population, were agreed upon with the FDA, with plans to enroll around 450 participants. The trial aims to evaluate ibezapolstat's clinical cure efficacy for CDI and its potential in reducing recurrence, with further analysis to test for superiority over vancomycin if non-inferiority is demonstrated.