Enanta begins Phase 2 clinical trial of protease inhibitor EDP-235 for Covid

Enanta Pharmaceuticals announced the initiation of SPRINT, SARS-Cov-2 PRotease INhibitor Treatment, a Phase 2 clinical trial of EDP-235, Enanta’s lead oral, 3CL protease inhibitor, in non-hospitalized, symptomatic adults with mild or moderate COVID-19. The study is designed to evaluate the safety, tolerability, and antiviral activity of 200mg and 400mg once-daily doses of EDP-235 compared to placebo. "The initiation of SPRINT is an important milestone in advancing the clinical development of EDP-235 as a once-daily antiviral treatment for COVID-19. Our recent encouraging Phase 1 data for EDP-235 demonstrated that 200mg and 400mg once-daily doses were safe and well-tolerated and provided plasma drug levels that were 7-fold and 13-fold, respectively, over the plasma protein adjusted EC90 for the Omicron variant, without the need for a boosting agent such as ritonavir and its associated drug-drug interactions," said Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals. "EDP-235 has the potential to be a best-in-class, one pill, once-a-day antiviral treatment for COVID-19 that can be easily prescribed and administered to reduce the burden of this disease on patients and our healthcare systems. As COVID-19 continues to present significant challenges worldwide, we remain confident in our expertise in infectious disease to combat this virus with a much-needed antiviral treatment that is active against all COVID-19 variants of concern. We look forward to reporting data from SPRINT in the first half of 2023."