The Qualified Infections Disease Product (QIDP) designation gives ACX-362E access to incentives including Priority Review and eligibility for Fast track status.
Acurx Pharmaceuticals, LLC today announced the US Food and Drug Administration (FDA) designated the company’s antibiotic product candidate, ACX-362E, a Qualified Infections Disease Product (QIDP). The FDA’s QIDP designation was granted for the treatment of patients infected with Clostridium difficile.
ACX-362E is being developed as a narrow spectrum oral antibiotic for patients with Clostridium difficile infection (CDI). Given the QIDP designation, the antibiotic will be eligible for certain benefits and incentives for the development of new antibiotics available under the Generating Antibiotic Incentives Now Act (the GAIN Act).
"We are very pleased that our lead antibiotic product candidate meets the FDA criteria and has been designated as a QIDP for oral use in patients with CDI, a life-threatening disease," said Robert J. DeLuccia, Co-Founder and Managing Partner of Acurx.
Acurx plans to file for Fast Track status with the FDA and begin a phase 1 clinical trial of the antibiotic in the fourth quarter of this year. The company anticipates its completion by the second quarter of 2019.
David P. Luci, Co-Founder and Managing Partner of Acurx, said, "Our ability to advance this antibiotic product candidate through clinical development and commercialize it, if approved, would constitute a significant advance for patients with CDI and treating physicians."
The Centers for Disease Control and Prevention (CDC) has designated Clostridium difficile as an urgent threat. A study of the burden of Clostridium difficile in the US, funded by the CDC found that in 2011 there were close to half a million Clostridium difficile infections, and that CDI was associated with about 29,000 deaths that year.
"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 DeLuccia.