Biopharmaceutical company Acurx Pharmaceuticals LLC revealed on Wednesday the receipt of the US Food and Drug Administration's Fast Track designation to facilitate the development and expedite the regulatory pathway of the investigational new treatment 362E for Clostridium difficile Infection (CDI).

The company said 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 to treat bacterial infections. It plans completing its Phase 1 clinical trial in the Q2 2019 and advance it into a Phase 2 clinical trial in the Q4 2019.

Under the US FDA's QIDP designation, ACX-362E will now be eligible to benefit from certain incentives for the development of new antibiotics provided under the Generating Antibiotic Incentives Now Act (the GAIN Act). These incentives include Priority Review and eligibility for Fast Track status as well as an additional five-year extension of Hatch-Waxman marketing exclusivity.

According to the company, ACX-362E is being developed as a targeted, narrow spectrum oral antibiotic for the treatment of patients with CDI.

In conjunction, the CDC has reported nearly 500,000 patients per year treated for CDI in the US alone, with a recurrence rate at 20% to 30%, with limited antibiotics available to treat patients. CDI is also prevalent in Europe, Japan and Canada. CDI is a life-threatening condition with persistent unmet medical need.