Acurx Announces FDA Has Granted an End of Phase 2 Meeting for Ibezapolstat for C. difficile Infection and the European Medicines Agency Granted SME Designation for Ibezapolstat EU Development
STATEN ISLAND, N.Y., Feb. 27, 2024 /PRNewswire/ — Acurx Pharmaceuticals, Inc. (NASDAQ: ACXP) (“Acurx” or the “Company”), a late-stage biopharmaceutical company developing a new class of small molecule antibiotics for difficult-to-treat bacterial infections, today announced that an EOP2 meeting has been granted by FDA to discuss the overall Phase 3 clinical and non-clinical development plan to support an NDA (New Drug Application) filing for ibezapolstat for the treatment of CDI. The Company submitted its Meeting Request earlier this month following successful completion of ibezapolstat’s Phase 2 clinical trial. On February 14, 2024, the FDA granted an EOP2 meeting which confirms adequate information was provided to warrant this type of meeting. In accordance with FDA Guidance (September 2023, REV1), the Company submitted its pre-meeting information Meeting Package (or Briefing Document) yesterday, February 26, 2024, which includes detailed information on the clinical development plan, including clinical pharmacology and clinical microbiology studies, to support the NDA filing, study design and statistical analysis plan for the Phase 3 studies.