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 investigated in a first-in-human phase 1 trial (ClinicalTrials.gov Identifier: NCT05246878) to assess safety, tolerability and pharmacokinetics. Trial participants will receive either EDP-235 or placebo in single escalating doses and multiple escalating doses.
According to the company, preclinical data shows that EDP-235 potently blocks SARS-CoV-2 replication in several cellular models, including primary human airway epithelial cells. The antiviral was also found to have good oral bioavailability without ritonavir stimulation and favorable distribution into lung cells.
“We believe the profile of EDP-235 positions it as a potential first-in-class antiviral therapy and we remain on track to report data from our ongoing Phase 1 study of EDP-235 in the next quarter. “said Jay R. Luly, PhD, President and CEO of Enanta Pharmaceuticals, the biotechnology company developing EDP-235.
FDA Fast Track designation helps expedite the development and review of products intended to treat serious, life-threatening conditions for which there is an unmet medical need.
Oral antiviral treatments currently authorized 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. Press 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-Specificically- Designed-for-the-treatment-and-prevention-of-COVID-19