ACX-362E is an orally administered antibiotic ready to enter clinical trials in the fourth quarter of 2018. It is a DNA polymerase inhibitor with a novel mechanism
of action by blocking the DNA replication process through inhibition of polymerase III (pol IIIC), a mechanism shown to be bactericidal, thereby effectively killing
C. difficile bacterial cells.
FDA has granted QUALIFIED INFECTIOUS DISEASE PRODUCT (QIDP) status for ACX-362E under the GAIN Act (section 505E(g) of the Federal
Food, Drug and Cosmetic Act) because it is an antibacterial intended to treat C. difficile infections which are serious or life threatening.
|pol IIIC enzyme
on C. difficile
to pol IIIC
Medical illustration of Clostridium
difficile, the bacteria that causes CDI
(C. difficile Infection)