Biopharmaceutical company Acurx Pharmaceuticals LLC revealed on Wednesday the receipt of the US Food and Drug Administration's (FDA) Qualified Infectious Disease Product (QIDP) designation for its lead antibiotic product candidate ACX-362E for treating Clostridium difficile infection (CDI).

Following 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), including Priority Review, eligibility for Fast Track status as well as an additional five-year extension of Hatch-Waxman marketing exclusivity following approval.

ACX-362E, which is being developed as a targeted, narrow spectrum oral antibiotic for the treatment of CDI, will enter into a Phase 1 clinical trial in the Q4 of 2018 and anticipates completing the Phase 1 clinical trial in the Q2 of 2019. The company plans to file for Fast Track status with the US FDA in Q4 2018.

According to the company, 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. There are nearly 500,000 patients per year treated for CDI in the US alone, with a recurrence rate approximated at 20% to 30%, with limited antibiotics available to treat these patients. CDI is also prevalent in Europe, Japan and Canada.