Acurx Pharmaceuticals LLC, a clinical stage, privately-held biopharmaceutical company focused on developing new antibiotics for difficult-to-treat bacterial infections, announced yesterday that it has received Fast Track designation from the United States Food and Drug Administration (FDA) for ACX-362E, an investigational new treatment for Clostridium difficile Infection (CDI).

The product is a novel, oral antibiotic that recently entered Phase one development. It is the first of a novel class of DNA polymerase IIIC inhibitors under development by Acurx to treat bacterial infections.

David P Luci, co-founder & managing partner of Acurx, said, 'FDA's granting of Fast Track designation for our lead antibiotic program validates our business model, which includes a pipeline of DNA polymerase IIIC Inhibitors we are currently developing to treat other resistant bacterial infections.'

Acurx intends to complete the drug's Phase 1 clinical trial in the second quarter of 2019 and is planning to advance ACX-362E into a Phase 2 clinical trial in the fourth quarter of 2019.