20 June 2018 - Acurx Pharmaceuticals today announced that the U.S. FDA has designated the Company's lead antibiotic product candidate, ACX-362E, as a qualified infectious disease product. 

ACX-362E is being developed as a targeted, narrow spectrum oral antibiotic for the treatment of patients with CDI. Acurx is planning to advance ACX-362E into a Phase 1 clinical trial in the fourth quarter of this year and anticipates completing the Phase 1 clinical trial in the second quarter of 2019. The CDC (Centers for Disease Control & Prevention) has designated Clostridium difficile bacteria as an urgent threat highlighting the need for new antibiotics to treat CDI.

Acurx intends to file for fast track status with the FDA in Q4 2018.

Read Acurx Pharmaceuticals press release