- Enanta Pharmaceuticals Inc ENTA has announced topline data from a Phase 1 study of EDP-235 in healthy adult subjects.
- EDP-235, a coronavirus 3CL protease inhibitor, is designed to be a once-daily, oral antiviral treatment for COVID-19.
- Data from the Phase 1 study demonstrated favorable safety, tolerability, and pharmacokinetics with strong exposure multiples over the EC90.
- Read Next: Safety Signals Force Enanta To Stop EDP-721 HBV Program.
- EDP-235 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 than plasma, driving exposure to 24-fold and 48-fold for the respective variants.
- 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.
- Price Action: ENTA shares closed at $49.70 on Thursday.
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