Core Insights - Acurx Pharmaceuticals is advancing its lead antibiotic candidate, ibezapolstat, into international Phase 3 clinical trials for the treatment of C. difficile Infection (CDI) [1][4][13] - The company has received FDA QIDP and Fast-Track Designation for ibezapolstat, highlighting its potential in addressing urgent medical needs [1][14] - The Phase 2 clinical trials demonstrated a high Clinical Cure rate of 96% for ibezapolstat, suggesting its efficacy compared to standard treatments [9][10] 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 [17][18] - The company's approach involves developing antibiotics with a Gram-positive selective spectrum, specifically targeting Clostridioides difficile and other resistant bacteria [17][18] Clinical Trial Updates - Acurx has successfully completed Phase 2 trials, with a favorable safety profile and significant microbiome preservation observed in patients treated with ibezapolstat [3][11][12] - The upcoming Phase 3 trials will include an estimated 450 subjects, randomized to receive either ibezapolstat or standard-of-care vancomycin, to assess non-inferiority and potential superiority [5][6] Regulatory Progress - The company has reached an agreement with the FDA on key elements for the Phase 3 trial design and is preparing to submit requests for regulatory guidance in the European Union, Japan, Canada, and the United Kingdom [4][5] Industry Context - C. difficile Infection remains a significant healthcare challenge, with estimates of 500,000 infections annually in the U.S. and a mortality rate of approximately 9.3% [15] - The CDC has classified C. difficile as an urgent threat, underscoring the need for new antibiotics like ibezapolstat to combat this infection [14][15]
Acurx Sponsored and Participated in the Peggy Lillis Foundation Inaugural CDI Scientific Symposium and Presented Ibezapolstat Ph2b Clinical Data Update