Acurx And Leiden University Reveal Major Breakthrough In C. difficile Treatment

Acurx Pharmaceuticals, Inc., a company specializing in advanced biopharmaceuticals, is excited to share the latest findings from its groundbreaking research on ibezapolstat. In collaboration with Leiden University Medical Center (LUMC), Acurx has been developing a novel class of small molecule antibiotics targeting challenging bacterial infections. 

These findings were showcased at the prestigious International C. difficile Symposium (ICDS) in Bled, Slovenia, from September 17-19, 2024. Dr. Wiep Klaas Smits, PhD, Associate Professor at LUMC, presented a talk titled "Structure of the Replicative Polymerase PolC Reveals Mode of Action and Mechanism of Resistance of the Anti-CDI Agent Ibezapolstat and Related Inhibitors.”

Dr. Smits stated that "Our findings with ibezapolstat regarding the structural biology of DNA pol IIIC inhibitors have important implications for the development of a new family of antibiotics to treat high priority, multi-drug resistant, gram-positive infections". He further stated: "I believe that DNA replication is a promising but underexplored target, and this novel class of DNA pol IIIC inhibitors could be an important new tool to address the pandemic of antimicrobial resistance”

Acurx has shared exciting news about its ibezapolstat treatment for C. difficile infection. The company successfully completed an FDA End-of-Phase 2 meeting and received the green light for Phase 3 preparations. They have finalized agreements with the FDA on key aspects needed to advance into international Phase 3 trials and have also secured approval for their comprehensive development plan, paving the way for a New Drug Application (NDA) submission. Acurx is moving forward with preparations to initiate these global trials and is also set to seek regulatory guidance for clinical trials in the European Union, the UK, Japan, and Canada.

Robert J. DeLuccia, Executive Chairman of Acurx, mentioned "We are very pleased with the outcome of our collaboration with LUMC which has been exceptionally productive." He added: "This detailed demonstration of the mode of action of DNA pol IIIC inhibitors in general, and for ibezapolstat specifically, is critically important to support our scientific foundation and our regulatory filings as we advance into this late-stage of ibezapolstat's development pathway toward commercialization".

The FDA has given the nod to the key aspects of the two pivotal Phase 3 trials for the non-inferiority study of ibezapolstat. This includes agreement on the trial design, patient criteria, primary and secondary endpoints, and the size of the safety database required for registration. Following FDA guidance and ahead of an EMA Scientific Advice Meeting, the primary efficacy analysis will utilize a Modified Intent-To-Treat (mITT) population, aligning with EMA standards. 

Approximately 450 subjects will be included in the mITT group, randomly assigned in a 1:1 ratio to receive either ibezapolstat or the standard treatment, vancomycin, in the initial Phase 3 trial. This design will evaluate ibezapolstat's effectiveness in achieving Clinical Cure of CDI two days after completing a 10-day oral regimen, and its potential to reduce CDI recurrence. Should ibezapolstat show non-inferiority compared to vancomycin, further analyses will explore its superiority.