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Enanta Pharmaceuticals Initiates SPRINT, a Phase 2 Clinical Trial of EDP-235, its Oral, Direct-Acting Antiviral Protease Inhibitor Specifically Designed for the Treatment of COVID-19
WATERTOWN, Mass.--(BUSINESS WIRE)-- Enanta Pharmaceuticals, Inc. (NASDAQ: ENTA), a clinical-stage biotechnology company dedicated to creating small molecule
About this update from Enanta Pharmaceuticals, Inc.
[{"type":"text","content":" WATERTOWN, Mass.--(BUSINESS WIRE)--\nEnanta Pharmaceuticals, Inc. (NASDAQ: ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections, today 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.\n\n“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.”\n\nThe randomized, double-blind, placebo-controlled study will enroll approximately 200 non-hospitalized, symptomatic patients with mild to moderate COVID-19, who are not at increased risk for developing severe disease. Patients will be eligible to participate if they have had symptoms for five days or less and have not received a SARS-CoV-2 vaccine or been infected with SARS-CoV-2 within 90 days of enrollment.\n\nPatients will receive EDP-235 orally at a dose of 200mg or 400mg or placebo once daily for five days. The primary objective of the study includes evaluation of safety and tolerability, and secondary objectives include the...