Acurx Pharmaceuticals Initiates Clinical Trial for Recurrent C. difficile Infection
Acurx Pharmaceuticals announced that it will conduct a new clinical trial in patients with recurrent C. difficile Infection while its program in the broader CDI patient population is ready to advance to Phase 3 international clinical trials, subject to receiving appropriate funding. This new clinical trial in rCDI begins with an open-label pilot trial to gain experience with IBZ in patients with multiply-recurrent CDI with at least 3 episodes of CDI within the past 12 months. This will inform elements of a planned active-controlled, Phase 3 registration trial in the rCDI indication to be implemented following favorable results from the open-label 20 patient trial. Upon subsequent successful completion of the Ph3 pivotal rCDI trial, and per the operative FDA procedure, Acurx plans to request FDA approval for treatment and prevention of rCDI under the FDA's Limited Population Pathway for Antibacterial and Antifungal Drugs.
