Breaking News: Acurx Receives Green Light from EMA for Ibezapolstat Phase 3 Program in Fight Against C. difficile Infection (CDI)
Description:
Acurx has now received positive written responses from the EMA (European Medicines Agency) under its Scientific Advice Procedure that the clinical, non-clinical and CMC (Chemistry Manufacturing and Controls) information package submitted supports advancement of the ibezapolstat Phase 3 program. The responses also included guidance on ibezapolstat’s regulatory pathway for a Marketing Authorization Application for ibezapolstat in CDI. With mutually consistent feedback from both EMA and FDA, Acurx is well positioned to commence our international Phase 3 registration program. Acurx is also preparing to request regulatory guidance to initiate clinical trials in Japan, Canada and the United Kingdom. Ibezapolstat has previously been granted FDA QIDP and Fast-Track Designation from FDA and Acurx has received SME (Small and Medium-sized Enterprise) designation by the EMA to benefit from fee incentives and other support from the EMA for EU Marketing Authorization. STATEN ISLAND, N.Y. , Jan. 6, 2025 /PRNewswire/ — Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) (“Acurx” or the “Company”) is a late-stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections, with its lead antibiotic candidate, ibezapolstat, preparing to advance to international Phase 3 clinical trials to treat patients with C. difficile infection.
Effect on Individuals:
For individuals affected by C. difficile infection, the advancement of Acurx’s ibezapolstat Phase 3 program brings hope of a new treatment option. This development may lead to improved outcomes and quality of life for patients suffering from this challenging bacterial infection. It offers a potential solution where other treatments may have failed, providing new possibilities for those in need of effective treatment for CDI.
Effect on the World:
The progress made by Acurx in receiving approval from the EMA for its Phase 3 program marks a significant step forward in the fight against C. difficile infection on a global scale. With the potential for international clinical trials and regulatory approval in multiple countries, the availability of a new class of small molecule antibiotics could have a positive impact on public health worldwide. This development may contribute to addressing antibiotic resistance and improving treatment options for bacterial infections not just in one region, but across different countries and healthcare systems.
Conclusion:
In conclusion, the green light received by Acurx from the EMA for its ibezapolstat Phase 3 program signifies a promising advancement in the battle against C. difficile infection. The potential for international trials and regulatory pathways opens doors for new treatment options for individuals affected by this challenging bacterial infection, while also holding the promise of a global impact by addressing antibiotic resistance and improving healthcare outcomes on a wider scale.
