FDA Approves Phase 2 Finalization Meeting and EMA Grants SME Status for Acurx's Ibezapolstat

Acurx Pharmaceuticals, a biopharmaceutical firm, is progressing with the development of ibezapolstat, a novel antibiotic for Clostridioides difficile Infection (CDI). The company has received approval from the FDA for an End of Phase 2 Meeting, scheduled for late April 2024, to finalize the Phase 3 development strategy. Acurx has also submitted a comprehensive Briefing Document to the FDA, detailing the clinical development plan for ibezapolstat, which includes pharmacology and microbiology studies.
Furthermore, the European Medicines Agency (EMA) has granted Acurx the Small and Medium-sized Enterprise (SME) designation, providing the company with financial incentives and support for the EU Marketing Authorization process. This designation is aimed at fostering innovation in smaller companies developing new medicinal products.
The Phase 2 clinical trial for ibezapolstat, which included both open-label and double-blind, randomized segments, demonstrated a high clinical cure rate of 96% in patients with CDI. The drug was well-tolerated, with mild gastrointestinal adverse events that resolved without treatment. Acurx decided to discontinue the Phase 2b trial early due to its success, which was based on blinded data and considerations such as the cost of maintaining trial sites and the impact of COVID-19 on enrollment.
Ibezapolstat, designated as a Qualified Infectious Disease Product (QIDP) by the FDA, is the first in a new class of antibiotics targeting DNA polymerase IIIC inhibitors. It has a unique spectrum of activity that preserves the gut microbiome while targeting C. difficile. The drug has also received Fast Track designation from the FDA, reflecting the urgent need for new treatments for CDI, which is a significant health concern in the U.S., with high infection and mortality rates.
Acurx's pipeline focuses on developing antibiotics with a Gram-positive selective spectrum that inhibits the enzyme DNA polymerase IIIC, leading to bacterial cell death. The company's goal is to bring ibezapolstat to the global market, building on the success of its U.S. clinical trials.