Acurx Pharmaceuticals Advances Ibezapolstat to Phase 3 Trials for C. Difficile Infections Following Regulatory Endorsements

Acurx Pharmaceuticals Advances Ibezapolstat to Phase 3 Trials for C. Difficile Infections

Acurx Pharmaceuticals, Inc., a late-stage biopharmaceutical company, has recently announced significant progress in its efforts to advance Ibezapolstat, a new antibiotic candidate aimed at treating patients suffering from C. difficile infections (CDI). Following a successful End of Phase 2 Meeting with the FDA, the company has secured favorable written feedback from both the FDA and the European Medicines Agency (EMA) regarding the readiness of their Phase 3 clinical trials.

Positive Regulatory Communications

Acurx's recent communications from the FDA confirmed the acceptability of their Chemistry Manufacturing and Controls (CMC) plan, which is crucial for supporting the upcoming Phase 3 clinical program. In tandem, the company has initiated the Scientific Advice procedure with the EMA to ensure a comprehensive understanding of the necessary steps to kickstart the Phase 3 clinical program in the European Union. Acurx anticipates receiving final written advice from the EMA in the coming weeks, solidifying their plans for international trials.

In a statement, Bob DeLuccia, Acurx's Executive Chairman, expressed satisfaction with the favorable responses from regulatory agencies, viewing them as validation of the strength of the company’s clinical data and regulatory submissions. He emphasized the importance of the forthcoming EMA advice and pediatric development plans in crafting a clear roadmap for the company’s clinical objectives.

Continuing Trial Preparations

The company is actively planning international trials, leveraging advanced AI technologies and other methodologies to identify and qualify clinical trial sites with the highest potential for patient enrollment. As part of its expansion, Acurx is preparing to solicit regulatory guidance for commencing clinical trials in additional territories, including Japan, Canada, and the United Kingdom.

Ibezapolstat has previously received the FDA's Qualified Infectious Disease Product (QIDP) designation, along with Fast Track designation, highlighting its potential impact in addressing severe bacterial infections. Additionally, Acurx has secured SME (Small and Medium-sized Enterprise) designation from the EMA, opening doors for fee incentives and support for EU Marketing Authorization.

Phase 3 Trial Details

The upcoming Phase 3 clinical trials are pivotal, focusing on the efficacy of Ibezapolstat compared to the standard antibiotic treatment, vancomycin. Key trial elements, including protocol design, patient demographic, primary and secondary endpoints, and safety database size, have been confirmed with the FDA. Acurx plans to employ a Modified Intent-To-Treat (mITT) analysis that will involve approximately 450 subjects during these trials, aiming at establishing both the clinical cure rate and the potential for reducing CDI recurrence.

The importance of demonstrating non-inferiority of Ibezapolstat to vancomycin is underscored by the promising results observed in earlier phases. The Phase 2 trials exhibited a remarkable Clinical Cure rate of 96%, with Ibezapolstat demonstrating a high degree of safety and tolerability among patients, as no drug-related serious adverse events were reported.

The Challenge of C. Difficile Infections

C. difficile remains a significant healthcare issue, exacerbated by its high recurrence rates. Current antibiotics used for treating CDI yield approximately 20% to 40% recurrence among treated patients, necessitating the development of novel treatments such as Ibezapolstat. The leading antibiotic candidate is positioned to offer a solution by overcoming previous treatment limitations, thereby contributing to better clinical outcomes.

The design of Ibezapolstat as a Gram-positive selective spectrum (GPSS®) antibiotic allows it to effectively target C. difficile while preserving the integrity of the gut microbiome, making it a unique alternative in this therapeutically challenging realm. The exciting prospect of entering Phase 3 trials represents a significant milestone for Acurx as they aim to combat this urgent public health threat head-on.

Conclusion

With strong support from regulatory bodies and an ongoing focus on robust clinical development, Acurx Pharmaceuticals is on track to make meaningful advancements in the fight against C. difficile infections. The successful management of upcoming Phase 3 trials will be critical for the company's quest to garner approval and, ultimately, bring Ibezapolstat to market.

For the latest updates on Acurx Pharmaceuticals and its innovative pipeline, visit www.acurxpharma.com.