Novel Antibiotic for C. Difficile Infection Gets FDA’s QIDP Designation

The Food and Drug Administration has granted Qualified Infectious Disease Product designation to ACX-362E (Acurx Pharmaceuticals) for the treatment of patients with Clostridium difficile infection (CDI). 

ACX-362E is a targeted, narrow spectrum oral antibiotic that blocks the DNA replication process through inhibition of polymerase III, which has been shown to be bactericidal. The Company is planning a Phase 1 clinical trial of the treatment in the fourth quarter of 2018, with an anticipated completion date during the second quarter of 2019. 

According to the Centers for Disease Control and Prevention almost 500,000 individuals are treated for CDI in the US each year. In 2013, the Agency designated Clostridium difficile as an urgent drug-resistant threat to the US.

“In an era of emerging bacterial threats where development of new antibiotics is needed, our new therapeutic approach has a novel mechanism of action and molecular target that qualifies it as a truly innovative anti-infective agent,” said Robert J. DeLuccia, managing partner of Acurx. 

For more information visit AcurxPharma.com.