Enanta Pharma Commences Dosing In Phase 1 COVID-19 Trial

Enanta Pharmaceuticals Inc ENTA has dosed the first subject in its Phase 1 trial of EDP-235, a coronavirus 3CL protease inhibitor, specifically designed as a once-daily, oral treatment for COVID-19.

• The Company plans to report data from this study in Q2 of 2022, and, assuming positive findings, Enanta expects to advance EDP-235 to the next stage of clinical development in 2H of 2022.
• This first-in-human Phase 1 study will evaluate the safety, tolerability, and pharmacokinetics of oral EDP-235 compared to placebo in healthy volunteers. 
• All SAD and MAD cohorts will enroll eight participants randomized to receive EDP-235 or placebo in a 3:1 ratio.
• Related: Enanta Plans To Start Human Trials For Its COVID-19 Candidate In 2022.
• Preclinical data show that EDP-235 potently blocks the replication of SARS-CoV-2 in multiple cellular models. 
• Preclinical studies demonstrate that EDP-235 has good oral bioavailability without ritonavir boosting and favorable distribution into lung cells and other key target tissues.
• Also See: Safety Signals Force Enanta To Stop EDP-721 HBV Program.
• Price Action: ENTA shares are down 2.99% at $60.35 during the market session on the last check Wednesday.