The Food and Drug Administration (FDA) has granted Fast Track designation to EPD-235, an investigational antiviral for the treatment and prevention of COVID-19.
EDP-235 is a coronavirus 3CL protease inhibitor, designed to be a once-daily, oral treatment for COVID-19. It is currently being examined in a first-in-human phase 1 trial (ClinicalTrials.gov Identifier: NCT05246878) to assess safety, tolerability, and pharmacokinetics. Trial participants will receive EDP-235 or placebo in single ascending doses and multiple ascending doses.
According to the Company, preclinical data show that EDP-235 potently blocks the replication of SARS-CoV-2 in multiple cellular models, including primary human airway epithelial cells. The antiviral was also found to have good oral bioavailability without ritonavir boosting and favorable distribution into lung cells.
“We believe that the profile of EDP-235 positions it as a potential best-in-class antiviral therapeutic and we remain on track to report data from our ongoing phase 1 study of EDP-235 next quarter,” said Jay R. Luly, PhD, President and CEO of Enanta Pharmaceuticals, the biotechnology company developing EDP-235.
The FDA’s Fast Track designation helps to accelerate the development and review of products intended to treat serious and life-threatening conditions for which there is an unmet medical need.
Currently authorized oral antiviral treatments for COVID-19 include molnupiravir and Paxlovid.
Enanta Pharmaceuticals receives FDA Fast Track designation for EDP-235, its oral 3CL protease inhibitor specifically designed for the treatment and prevention of COVID-19. News release. Enanta Pharmaceuticals. March 29, 2022. https://www.businesswire.com/news/home/20220329005158/en/Enanta-Pharmaceuticals-Receives-FDA-Fast-Track-Designation-for-EDP-235-its-Oral-3CL-Protease-Inhibitor-Specifically-Designed-for-the-Treatment-and-Prevention-of-COVID-19