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.


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“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.

Reference

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

This article originally appeared on MPR