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Enanta Pharmaceuticals Announces Positive Topline Results from First-in-Pediatrics Phase 2 Study Evaluating Zelicapavir for the Treatment of Respiratory Syncytial Virus (RSV)
Observed an antiviral effect for the primary and secondary virology endpoints in the overall population, with a viral load decline of 1.4 log at the end of
About this update from Enanta Pharmaceuticals, Inc.
[{"type":"text","content":"\n\nObserved an antiviral effect for the primary and secondary virology endpoints in the overall population, with a viral load decline of 1.4 log at the end of treatment in Part 2\n\n\n\nDemonstrated a viral load decline of 1.2 log compared to placebo at the end of treatment in prespecified analysis of patients randomized within 3 days of symptom onset\n\n\n\nZelicapavir was well-tolerated with a favorable safety profile\n\n\n\nConference call and webcast to discuss data at 8:30 a.m. ET today\n\n\n\n WATERTOWN, Mass.--(BUSINESS WIRE)--\nEnanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for virology and immunology indications, today announced positive topline results from the first-in-pediatrics Phase 2 study evaluating zelicapavir in hospitalized and non-hospitalized children aged 28 days to 36 months with respiratory syncytial virus (RSV). An antiviral effect was observed for the primary and secondary virology endpoints in the overall pooled efficacy population. The primary endpoint in Part 2 of the study, which focused on virology, showed a pronounced antiviral effect with a 1.4 log decline in viral load at Day 5 compared to placebo. Additionally, a rapid and robust virologic effect was observed in a prespecified subset of patients who were randomized within 3 days of symptom onset, with a 1.2 log decline in viral load at Day 5 compared to placebo. The study also showed that zelicapavir demonstrated a favorable safety profile and was well-tolerated in this pediatric population. Zelicapavir, which received Fast Track designation from the U.S. Food and Drug Administration (FDA), is a novel N-protein inhibitor in development as a once-daily oral treatment for RSV.\n\n\n“We are excited to share these positive results from our first-in-pediatric Phase 2 study of zelicapavir, which we believe confirm a strong profile for our lead RSV antiviral and strengthen Enanta’s position as a leader in developing treatments for RSV. Zelicapavir demonstrated an antiviral effect on both primary endpoints, as well as secondary virology endpoints. Furthermore, patients who joined the study within 3 days of symptom onset showed a robust 1.2 log reduction in viral load at Day 5. These data provide us with continued confidence in zelicapavir and valuable insights to inform the...