Enanta Pharmaceuticals Doses First Patient In Its RESOLVE Phase 2b/3 Clinical Trial Of Zelicapavir In Adults At High Risk Of Severe Outcomes From RSV; Topline Data Expected In 2027

The Phase 2b/3 randomized, double-blind, placebo-controlled, multicenter global trial will evaluate the efficacy and safety of zelicapavir in adult outpatients who test positive for RSV and have had respiratory tract infection symptoms for no more than 3 days. Patients will have at least one of the following risk factors: 75 years of age or older, chronic obstructive pulmonary disease, or congestive heart failure. These risk factors are the same as the HR3 population in the Company’s previous Phase 2 RSVHR trial where a one-week reduction in time to complete resolution of symptoms, as well as a reduction in hospitalization, were observed. Patients will receive an oral dose of 800mg of zelicapavir or placebo once daily for 7 days and be evaluated for 28 days thereafter. The primary endpoint is the time to complete resolution of all 13 RSV symptoms as measured by the RiiQ™ tool. A key secondary endpoint will evaluate hospitalization rate, with other secondary endpoints of additional clinical efficacy measures, antiviral activity, and safety of zelicapavir. The Phase 2b portion of the study will include a minimum of 200 patients and is designed to confirm the treatment effect size on the primary and key secondary endpoints in the targeted population, while the Phase 3 portion of the study is expected to enroll approximately 660 patients.