Biopharmaceutical company focused on developing new antibiotics for difficult-to-treat bacterial infections, Acurx Pharmaceuticals announced today that the U.S. Food and Drug Administration has granted Fast Track designation for ACX-362E, an investigational new treatment for Clostridium difficile Infection (CDI).  ACX-362E is a novel, oral antibiotic that recently entered Phase 1 development.

Clostridium difficile Image/CDC
Clostridium difficile

ACX-362E is a novel, first-in-class, orally-administered antibacterial. It is the first of a novel class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections.

“The FDA’s decision to grant Fast Track Designation for ACX-362E corroborates our effort to develop a new, highly innovative treatment option for patients with CDI, an area of significant unmet need,” said Robert J. DeLuccia, Co-Founder & Managing Partner of Acurx. “If approved, we believe our new antibacterial, ACX-362E, will be an important therapeutic alternative for patients with CDI.  The Fast Track designation will allow Acurx to work more closely with the FDA to bring ACX-362E to physicians and patients as soon as possible.”

FDA Fast Track Designation is a process designed to facilitate the development and expedite the regulatory pathway of new drugs to treat serious or life-threatening conditions and that fill a high unmet medical need.

The CDC has reported that there are nearly 500,000 patients per year treated for CDI in the U.S. alone, with a recurrence rate approximated at 20% to 30%, with limited antibiotics available to treat patients with CDI.