FDA grants Fast Track status to new C difficile antibiotic
The US Food and Drug Administration (FDA) has granted Fast Track designation to a new investigational antibiotic for Clostridioides difficile infection (CDI), according to a press release yesterday from Acurx Pharmaceuticals.
ACX-362E is a novel, narrow-spectrum oral antibiotic based on inhibition of the enzyme DNA polymerase IIIC, which is required for bacterial replication and pathogenesis in C difficile.
The drug is currently being tested in a phase 1 clinical trial. The company expects to launch a phase 2 trial at the end of year.
Under the Fast Track designation, ACX-362E will receive expedited review from the FDA. The agency grants the designation to drugs that treat serious or life-threatening conditions and fulfill an unmet medical need. The CDC has identified C difficile, which sickens nearly 500,000 Americans each year, as an urgent threat.
“If approved, we believe our new antibacterial, ACX-362E, will be an important therapeutic alternative for patients with CDI,” Acurx managing partner Robert DeLuccia said in the press release. “The Fast Track designation will allow Acurx to work more closely with the FDA to bring ACX-362E to physicians and patients as soon as possible.”
Jan 16 Acurx Pharmaceuticals press release