AcuRx announced that the Food and Drug Administration (FDA) has granted Fast Track Designation for ACX-362E for the treatment of Clostridium difficile infection (CDI). 

ACX-362E is a first-in-class, DNA polymerase IIIC inhibitor oral antibiotic. Its mechanism of action involves selective inhibition of DNA polymerase IIIC, which is required for bacterial replication and pathogenesis.  

The investigational drug is currently in Phase 1 development, with completion expected in the second quarter of 2019; a Phase 2 trial is being planned for the 4th quarter of 2019. 

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“The FDA’s decision to grant Fast Track Designation for ACX-362E corroborates our effort to develop a new, highly innovative treatment option for patients with CDI, an area of significant unmet need,” said Robert J. DeLuccia, Co-Founder & Managing Partner of Acurx. According to the Centers for Disease Control and Prevention (CDC), C. diff causes almost half a million infections among patients in the US per year.

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