Acurx announces successful FDA end-of-phase 2 meeting and phase 3 readiness for Ibezapolstat in the treatment of C. difficile infection. The successful meeting outcomes include reaching key elements of Phase 3 clinical trial program and a development plan of NDA filling. C. difficile infection (CDI) is a bacterial infection of the colon, and causes diarrhea and colitis.
Ibezapolstat is a novel antibacterial agent that acts specially on DNA pol IIIC enzyme through competitive inhibition of dGTP (guanosine analog). Ibezapolstat has been granted Fast Track Designation from the U.S. FDA.