WATERTOWN, Mass.--(BUSINESS WIRE)-- Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced the initiation of a Phase 2b, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of EDP-938, its novel N-protein inhibitor, in adults with acute respiratory syncytial virus (RSV) infection who are at high risk of complications, including the elderly and/or those with congestive heart failure, chronic obstructive pulmonary disease (COPD) or asthma.
“We are excited to expand our RSV program with the progression of EDP-938 into another trial of high-risk patients, where we believe that treatment with our compound has the greatest potential to show optimal efficacy and clinical benefit,” commented Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals. “We are eager to advance our broad clinical development plan that is focused on evaluating EDP-938 in these patients that have the greatest unmet need, continuing with our strategy of targeting populations at high-risk for RSV. In previous clinical studies, EDP-938 significantly improved the percentage of people with undetectable RSV RNA at the end of treatment, consistent with inhibiting viral replication. Additionally, EDP-938 has a favorable and consistent safety profile in approximately 500 people exposed to date. As we progress this study and advance our pipeline, we look forward to continuing to build our leadership position in this disease area.”
The Phase 2b, randomized, double-blind, placebo-controlled, multi-center, global study is designed to evaluate the effect of EDP-938 compared with placebo on the progression of RSV infection by assessment of clinical symptoms. Approximately 180 patients will be treated with 800 mg of EDP-938 or placebo for 5 days and evaluated for 28 days thereafter. The study will include non-hospitalized adult subjects with up to 72 hours of respiratory tract infection symptoms who test positive for RSV and negative for influenza virus and SARS-CoV-2. Patients will be considered high risk for complications after RSV infection if they have at least one of the following risk factors: age 65 years or older, congestive heart failure, COPD or asthma. The primary endpoint of the study is time to resolution of RSV lower respiratory tract disease symptoms as assessed by the Respiratory Infection Intensity and Impact Questionnaire (RiiQ™) symptom scale through Day 33. Secondary endpoints include additional clinical efficacy measures and antiviral activity compared to placebo, pharmacokinetics, and safety of EDP-938.
About EDP-938 EDP-938, Enanta’s lead N-protein inhibitor, is being developed for the treatment of RSV infection, and has been granted Fast Track designation by the U.S. Food and Drug Administration. EDP-938 is a nanomolar inhibitor of both RSV-A and RSV-B activity. EDP-938 is differentiated from RSV fusion inhibitors as the N-protein inhibitor targets the virus’ replication machinery and has demonstrated a high barrier to resistance in vitro. In preclinical studies, EDP-938 maintained antiviral potency across all clinical isolates tested and was active against viral variants resistant to other mechanisms. EDP-938 demonstrated a favorable safety, pharmacokinetic and drug-drug interaction profile in an extensive Phase 1 program. In a Phase 2 challenge study, EDP-938 achieved highly statistically significant (p