Enanta announces data from Phase 1 study of EDP-235 07:21 ENTA Enanta Pharmaceuticals announced positive topline data from a Phase 1 study assessing the safety, tolerability, and pharmacokinetics, PK, of orally administered single ascending doses, SAD, and multiple ascending doses, MAD, of EDP-235 in healthy adult subjects. EDP-235, a coronavirus 3CL protease inhibitor, which received Fast Track designation from the U.S. Food and Drug Administration, is specifically designed to be a once-daily, oral antiviral treatment for COVID-19. Data from the Phase 1 study demonstrated favorable safety, tolerability, and PK with strong exposure multiples over the EC90, thereby supporting the advancement of EDP-235 into a Phase 2 study using once-daily dosing, without ritonavir. "We are very pleased with the encouraging results from our Phase 1 study of EDP-235 showing that it was generally safe and well-tolerated up to a once-daily dose of 400mg, which provided plasma drug levels that were 6-fold and 12-fold over the plasma protein adjusted EC90 for the Alpha variant and the Delta variant, respectively. Moreover, EDP-235 is projected to have four times higher drug levels in lung tissue compared to plasma, which would drive exposure multiples to 24-fold and 48-fold for the respective variants," stated Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals. This first-in-human, randomized, double-blind, placebo-controlled Phase 1 study enrolled healthy volunteers to evaluate the safety, tolerability, and PK of oral EDP-235 in SAD and MAD for seven days, and the effect of food. A total of 72 subjects received at least one dose of EDP-235 or placebo. Overall, EDP-235 was generally safe and well-tolerated in healthy subjects up to 400mg for up to seven days. The majority of adverse events were mild, with headache and gastrointestinal related symptoms being the most frequently reported AEs during the MAD phase. There were three study discontinuations: one moderate headache in the 400mg fasted cohort, one severe headache in the 800mg fed cohort and one grade 3 ALT/grade 2 AST elevation in the 800mg fed cohort. EDP-235 exposure increased approximately proportionally with increasing single and multiple doses, with a consistent half-life ranging from 13 to 22 hours, resulting in a PK profile suitable for once-daily dosing. Exposure was enhanced with food administration of a standard meal. EDP-235 once-daily taken with food, resulted in mean trough plasma levels at steady state that were higher than the plasma protein adjusted EC90 of EDP-235 in Vero. Based on these positive data, Enanta is moving forward with the clinical development of EDP-235, targeting a fourth quarter initiation of a Phase 2 study exploring doses of 200mg and 400mg once-daily, pending review with the FDA.
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