Enanta Pharmaceuticals ENTA reported positive topline data from a Phase 1 study evaluating the safety, tolerability, and pharmacokinetics (PK) of orally administered single and multiple ascending doses of EDP-235 in healthy adult subjects.
EDP-235 is specifically designed to be a once-daily, oral antiviral treatment for COVID-19. EDP-235 was generally safe and well-tolerated in healthy subjects up to 400mg for up to seven days.
The 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.
Jay R. Luly, President and Chief Executive Officer, commented: “"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.”
With this positive data readout, the company is planning to initiate a Phase 2 clinical study of EDP-235 in the fourth quarter, exploring doses of 200mg and 400mg once-daily, pending review with the regulatory agency.
Price Action: Enanta shares are trading around 4 percent at $51.59 on Friday at the time of publication.
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