FDA Fast Tracks Oral Antibiotic for C Difficile Treatment

The US Food and Drug Administration (FDA) has granted Fast Track designation to ACX-362E, an investigational new treatment for Clostridium difficile infection (CDI). The oral antibiotic is being developed by Acurx Pharmaceuticals, LLC, as a targeted, narrow spectrum antibiotic and has recently entered a phase 1 clinical trial.

"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," Robert J. DeLuccia, Co-Founder and Managing Partner of Acurx, said in a statement. "If approved, we believe our new antibacterial, ACX-362E, will be an important therapeutic alternative for patients with CDI. 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."

In June 2018, the FDA designated ACX-362E as a Qualified Infections Disease Product (QIDP) for the treatment of patients with C difficile infection. This designation means the antibiotic is eligible for certain benefits and incentives for the development of new antibiotics available under the Generating Antibiotic Incentives Now Act (the GAIN Act), including Priority Review and eligibility for the Fast Track status it has just received.

The company anticipates the completion of the ACX-362E phase 1 clinical trial in the second quarter of 2019. A phase 2 clinical trial is planned to begin in the fourth quarter of 2019.

The Centers for Disease Control and Prevention (CDC) designated C difficile as an urgent threat. A study of the burden of C difficile in the US, funded by the CDC, found that in 2011 there were close to half a million C difficile infections, and that CDI was associated with about 29,000 deaths that year.

"FDA's granting of Fast Track designation for our lead antibiotic program validates our business model which includes a pipeline of DNA polymerase IIIC Inhibitors we are currently developing to treat other resistant bacterial infections," added David P. Luci, Co-Founder and Managing Partner of Acurx, in a statement.