Enanta Pharmaceuticals Announces Advancement of its Zelicapavir Clinical Development Program for the Treatment of Respiratory Syncytial Virus (RSV)

About this update from Enanta Pharmaceuticals, Inc.

Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and immunological diseases, today announced it is advancing zelicapavir into a registrational Phase 2b/3 clinical trial in adults at high risk of severe outcomes from RSV infection after a successful End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA). The Phase 2b portion of the trial will confirm the treatment effect with topline data expected in 2027. Enanta also announced plans to initiate a Phase 2b clinical trial of zelicapavir in pediatric patients with RSV, with topline data expected in 2027. “We are thrilled to move zelicapavir into a single Phase 2b/3 registrational clinical trial in adults with RSV at high risk of progressing to severe disease, following a productive and collaborative End-of-Phase 2 meeting with the FDA. This progress, alongside the planned initiation of our pediatric Phase 2b trial, provides the opportunity for two key Phase 2b datasets next year in two important patient populations and underscores zelicapavir’s potential to become the first antiviral therapy for RSV infection,” said Jay R. Luly, Ph.D., President and Chief Executive Officer of Enanta Pharmaceuticals. “RSV results in a substantial global disease burden, with no available treatment options. We estimate an oral RSV antiviral for children and all high-risk adults represents a global market opportunity of over $2 billion, with a potential total addressable population of greater than 3 million patients in the United States alone. The recent availability of at-home RSV diagnostics is expected to further drive disease awareness and increase earlier diagnosis. As we advance into late-stage development, we are well-positioned to continue our leadership in RSV and remain urgently focused on delivering zelicapavir to patients in need of treatment.” “We now have a clear and efficient pathway to advance zelicapavir into a registrational program through a single Phase 2b/3 trial. The Phase 2b part is designed to confirm the primary endpoint and treatment effect size in the targeted population and will provide a key dataset to further strengthen the body of evidence supporting the Phase 3 portion of the study. We look forward to beginning the trial in the fourth quarter of 2026, with data from the Phase 2b porti...

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