Zelicapavir Shows Promising Antiviral Effect in Pediatric RSV Study
Zelicapavir Efficacy:
Zelicapavir, an N-protein inhibitor developed by Enanta Pharmaceuticals, demonstrated a significant antiviral effect in a Phase 2 study involving hospitalized and non-hospitalized pediatric patients with RSV aged 28 days to 36 months14.
Viral Load Reduction:
The study showed a viral load decline of 1.4 log at day 5 and 0.7 log at day 9 compared to placebo. In patients randomized within 3 days of symptom onset, a more pronounced effect was observed, with a viral load decline of 1.2 log at day 514.
Safety Profile:
Zelicapavir was well-tolerated with a favorable safety profile. Adverse events were similar between treatment groups, with no events leading to treatment discontinuation or withdrawal from the study14.
Fast Track Designation:
Zelicapavir has been granted Fast Track Designation by the FDA, indicating its potential to address a significant unmet need in treating RSV infections1.
Study Design:
The Phase 2 study was a randomized, double-blind, dose-ranging, and placebo-controlled trial, evaluating both the safety and antiviral activity of zelicapavir in pediatric patients14.
Clinical Significance:
The study's positive results underscore the potential of zelicapavir as a safe and effective antiviral therapeutic for pediatric RSV infections, addressing a critical unmet need in pediatric healthcare14.
Sources:
1. https://www.contemporarypediatrics.com/view/zelicapavir-demonstrates-antiviral-effect-in-phase-2-rsv-study
4. https://ir.enanta.com/news-releases/news-release-details/enanta-pharmaceuticals-announces-positive-topline-results-first