#United States #Ibezapolstat #C. difficile #Staten Island #Acurx Pharmaceuticals

Acurx Pharmaceuticals Gains Positive Opinion from EMA

Acurx Pharmaceuticals Inc., a late-stage biopharmaceutical firm, has officially announced that the Paediatric Committee (PDCO) of the European Medicines Agency (EMA) issued a favorable opinion regarding their Pediatric Investigation Plan (PIP) for ibezapolstat's use in treating children affected by C. difficile infection (CDI). This opinion is a significant milestone as it aligns with the regulatory requirements essential for the initiation of Phase 3 clinical trials within the European Union.

Understanding C. difficile Infection

Clostridioides difficile is recognized globally as the leading infectious cause of antibiotic-induced diarrhea, with an increasingly alarming number of cases reported among children, reaching approximately 20,000 annually in the U.S. Notably, CDI in children often presents as a community-associated infection, accounting for up to 75% of cases, with incidences ranging from asymptomatic carriers to critical diarrhea episodes. Although severe cases are relatively rare in children, they pose significant health risks including prolonged morbidity and potential fatality.

Acurx's Executive Chairman, Bob DeLuccia, expressed satisfaction over this EMA opinion, emphasizing the urgent need for innovative antibiotic treatments for young patients suffering from CDI. He noted, “Our pediatric clinical trial program aims to demonstrate that ibezapolstat will be a safe and effective treatment, potentially transforming how we approach CDI in this vulnerable population.”

The Importance of Pediatric Investigation Plans (PIPs)

A Pediatric Investigation Plan is a strategic framework aimed at gathering necessary data to support the safe and effective use of new treatments in children. The EMA mandates pharmaceutical companies to outline their developmental strategies for medications targeting pediatric populations, and a validated PIP is a prerequisite for filing a Marketing Authorization Application (MAA). Acurx aims to submit an integrated PIP to the U.S. FDA as part of their global strategy that will further support regulatory approval efforts.

Advancements in Research and Clinical Trials

The favorable EMA opinion positions Acurx to commence international Phase 3 trials. The company previously received FDA designations for ibezapolstat including Qualified Infectious Disease Product (QIDP) and Fast Track, indicating a well-structured path forward. During preliminary studies, they demonstrated significant efficacy in treating CDI, with a Clinical Cure rate of 96% in combined Phase 2 trials involving ibezapolstat, showcasing improved outcomes compared to traditional treatments.

Ibezapolstat is known to maintain the gut microbiome while effectively targeting bacteria causing CDI, a vital aspect given the recent studies indicating the potential for healthy gut bacteria restoration post-infection. This innovation may not only lead to a higher cure rate but also minimize recurrence rates and overall antibiotic exposure in children, enhancing long-term microbiome health.

Concluding Remarks

As Acurx Pharmaceuticals continues to make progress in its clinical trials, the positive EMA opinion on their Pediatric Investigation Plan for ibezapolstat provides hope for children suffering from C. difficile infections. Their commitment to developing a targeted and effective treatment is a major step forward in addressing one of the most pressing medical needs in pediatric healthcare. The anticipated benefits of ibezapolstat could pave the way for more effective pediatric treatments, ensuring that children receive the care they need without compromising their gut health. Acurx remains focused on leveraging this momentum as they approach Phase 3 trials while also aligning with U.S. regulations to ensure safety and efficacy in both markets.

About Acurx Pharmaceuticals

Acurx Pharmaceuticals is dedicated to developing a new class of antibiotics specifically aimed at hard-to-treat bacterial infections, including CDI. As they prepare for the global Phase 3 clinical trials, Acurx exemplifies the innovation necessary to advance antibiotic therapy, addressing critical health care needs through scientific rigor and a commitment to patient care.