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Acurx Pharmaceuticals Prepares for Phase 3 Trials of Ibezapolstat Against C. Difficile Infection

Acurx Pharmaceuticals, Inc., a late-stage biopharmaceutical company, has announced encouraging news regarding its lead antibiotic candidate, Ibezapolstat. Following successful communication with the European Medicines Agency (EMA), Acurx is set to advance its Phase 3 clinical trials designed to tackle Clostridioides difficile infections (CDI). This statement comes as the EMA provided favorable regulatory guidance, affirming the strength of Acurx's clinical data and the commercial plan based on the information package submitted for review.

The positive responses from the EMA ensure that Acurx is well-positioned to initiate its international Phase 3 registration program. This program includes two pivotal non-inferiority trials that compare Ibezapolstat to vancomycin, a standard treatment for CDI. The trials are designed with a focus on the patient population, primary endpoints, and sample size, featuring up to 450 subjects randomized in a 1:1 ratio between Ibezapolstat and vancomycin. Advantages of Ibezapolstat could lead to substantial improvements in treatment outcomes if non-inferiority is achieved.

Bob DeLuccia, Executive Chairman of Acurx, highlighted the significance of the EMA's recommendations and stated that the company will take these suggestions into account as it establishes a global approach for its registration strategy. The EMA's endorsement complements similar feedback previously received from the FDA, showcasing a coherent pathway that supports Acurx’s ambitions to successfully navigate the clinical trial landscape.

The Phase 3 trials will aim to demonstrate the efficacy of Ibezapolstat—not only in achieving clinical cures quickly but also in preventing the recurrence of CDI. In preliminary Phase 2 trials, Ibezapolstat was administered to patients suffering from CDI, showing a promising clinical cure rate of 96%, undoubtedly placing Acurx in a confident position as it prepares for expanded clinical efforts.

Initial investigations led to significant insights regarding the microbiome's role in C. difficile infections. By preserving beneficial gut flora while combating pathogenic bacteria, Ibezapolstat continues to show a low incidence of side effects compared to conventional treatments. In comparative studies, Ibezapolstat treated patients exhibited a higher ratio of secondary bile acids, which is associated with lower rates of recurrence.

The impending trials will focus on two main phases: Phase 2a, where patients exhibited complete recovery, and the more extensive Phase 2b trials that emphasized the drug’s comparable effectiveness to vancomycin. This extensive background fortifies its application for broader approval across multiple international markets.

As Acurx aims to benefit from its Small and Medium-sized Enterprises (SME) status, this designation by the EMA grants them potential fee incentives and support, further demonstrating the company's commitment to bringing this groundbreaking treatment to market efficiently. Future plans include seeking regulatory guidance to initiate clinical trials in Japan, Canada, and the United Kingdom, expanding Ibezapolstat's reach across crucial global markets.

In conclusion, the recent favorable feedback from EMA solidifies Acurx Pharmaceuticals' trajectory to advance Ibezapolstat through Phase 3 trials. The overwhelming data gathered from earlier studies showcases the potential of this new antibiotic class targeting C. difficile infections, providing hope for patients and healthcare providers alike in the face of challenging antibiotic-resistant infections. As the company prepares for the next steps, the medical community remains optimistic about Acurx's forward momentum and potential breakthrough in CDI treatment.