Enanta Pharmaceuticals(US:ENTA)2025-09-29 12:30Study Overview - The Phase 2b RSVHR study (n=186) aimed to demonstrate a clinically meaningful reduction in symptom duration of at least ~1 day in high-risk adults treated with Zelicapavir [12] - The study's primary objective was to assess the time to resolution of RSV lower respiratory tract disease (LRTD) symptoms [15] - The study randomized 186 adults with COPD, congestive heart failure, asthma, or age ≥65 [15] Efficacy Results - Zelicapavir resulted in faster complete symptom resolution across multiple RiiQTM measures [33] - In the HR3 population, Zelicapavir showed a 3-day faster time to complete resolution of LRTD symptoms, a 6.7-day faster time to complete resolution of all RSV symptoms, and a 7.2-day faster time to complete resolution of total RiiQ 29 parameters compared to placebo [34, 39] - The study showed a statistically significant 2-day faster symptom resolution by PGI-S compared to placebo in both the efficacy (p=0.0446) and HR3 populations (p=0.0465) [36, 38, 40] Safety and Additional Endpoints - The study exhibited a favorable safety profile, with adverse events (AEs) being similar between the Zelicapavir and placebo groups [29, 31] - The hospitalization rate was lower for patients treated with Zelicapavir: 1.7% (2/115) vs 5.0% (3/60) on placebo [42] - A greater proportion of patients treated with Zelicapavir had undetectable viral load at the end of treatment in the Efficacy Population: 23.5% (27/115) vs 10.0% (6/60) (p=0.0198) and in the HR3 Population: 23.9% (22/92) vs 10.0% (5/50) (p=0.0292) [43] - Zelicapavir showed a viral load decline of 0.7 log at the end of treatment in the HR3 population [44, 45]