Acurx Receives Positive EMA Opinion On Pediatric Investigation Plan For Ibezapolstat In Children With C. Difficile Infection

Acurx Pharmaceuticals, Inc., a late-stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections, announced that it has received a positive opinion from the Pediatric Committee (PDCO) of the European Medicines Agency (EMA) on its Pediatric Investigation Plan (PIP) for ibezapolstat in children with Clostridioides difficile infection (CDI).

CDI is the leading cause of antibiotic-associated diarrhea worldwide and a major healthcare-associated infection in the United States. The incidence of CDI in children has been rising, with approximately 20,000 cases reported annually. In pediatric patients, CDI is more frequently community-associated, accounting for around 75% of cases. The disease can range from asymptomatic carriage to severe diarrhea, with fulminant cases, though rare, carrying high morbidity and potential fatality. Recurrence is also common, affecting 20% to 30% of children after an initial infection. 

Despite recent advances in understanding and managing CDI in children, there remains a significant need for effective therapies, particularly for severe and recurrent cases. Bob DeLuccia, Executive Chairman of Acurx, said that the positive EMA opinion is an important milestone in the company’s regulatory pathway, highlighting the unmet need for innovative antibiotics to treat pediatric CDI. He noted that Acurx’s pediatric clinical program aims to demonstrate that ibezapolstat is a safe and effective treatment capable of curing CDI, reducing recurrences, and preserving the gut microbiome in children. 

Additionally, successful approval of ibezapolstat could qualify for an extra year of marketing exclusivity in Europe, on top of the 10-year exclusivity period granted for a new class of antibiotic under a successful Marketing Authorization Application (MAA). This positive opinion supports Acurx’s commitment to advancing ibezapolstat as a transformative therapy for children affected by CDI and addresses a critical gap in pediatric infectious disease treatment.