Acurx Pharmaceuticals, a clinical stage biopharmaceutical company developing a new class of antibiotics for difficult-to-treat bacterial infections, today announced that it will conduct a new clinical trial in patients with recurrent c. difficile Infection (rCDI) while its programme 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 three 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 favourable 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 (Guidance for Industry, 2020).
Results of the above-mentioned experimental data from the University of Houston laboratory of Dr Kevin Garey, has been submitted in abstract form to the Anaerobe Society of the Americas scientific conference 7-10 July 2026, at Columbia University in New York and will be publicly disclosed shortly thereafter.
