Acurx Announces Positive Comparative Microbiology and Microbiome Data for Ibezapolstat from Phase 2b Clinical Trial in CDI Patients

Core Insights - Acurx Pharmaceuticals announced that its lead antibiotic candidate, ibezapolstat, demonstrated superior efficacy compared to vancomycin in eradicating fecal C. difficile in a Phase 2b clinical trial, achieving a 94% eradication rate versus vancomycin's 71% [1][3][6] - Ibezapolstat preserved key gut bacterial species that are believed to help prevent recurrence of Clostridioides difficile infection (CDI), a significant advantage over vancomycin [1][2][11] - The company is preparing for meetings with regulatory agencies and advancing towards international Phase 3 clinical trials, following positive results from the Phase 2b trial [1][3][12] Company Overview - Acurx Pharmaceuticals is a late-stage biopharmaceutical company focused on developing a new class of small molecule antibiotics targeting difficult-to-treat bacterial infections, including CDI [16] - The company’s lead candidate, ibezapolstat, is a Gram-Positive Selective Spectrum (GPSS™) antibiotic that inhibits DNA polymerase IIIC, contributing to its unique mechanism of action [11][16] - Ibezapolstat has received FDA designations such as Qualified Infectious Disease Product (QIDP) and Fast-Track, highlighting its potential in addressing urgent medical needs [12][16] Clinical Trial Insights - The Phase 2b trial involved 32 patients with CDI, randomized to receive either ibezapolstat or vancomycin, with a follow-up period to assess recurrence [6][8] - The overall clinical cure rate for ibezapolstat across both Phase 2 trials was 96%, indicating strong efficacy [6][8] - The trial was discontinued early due to the observed success, allowing for expedited progression to Phase 3 trials [7][8] Market Potential - The U.S. CDI market is estimated to exceed $1 billion, and Acurx anticipates that ibezapolstat could be competitively priced compared to existing antibiotics [3][12] - The company aims to leverage its clinical data to differentiate ibezapolstat in the market, focusing on both efficacy and microbiome health [3][12] Future Developments - Further analyses from the Phase 2b trial, including Extended Clinical Cure (ECC) data, are expected in Q1 2024 [1][2] - Acurx is preparing for an end of Phase 2 meeting with the FDA, targeted for the second quarter of 2024, to discuss the next steps for ibezapolstat [2][3]