Enanta Pharmaceuticals, Inc. announced topline data from RSVHR, a Phase 2b, randomized, double-blind, placebo-controlled study of zelicapavir. The study evaluated the efficacy and safety of zelicapavir in outpatient adults with acute RSV infection who are at high risk of complications.
Zelicapavir missed its primary endpoint in the study. However, the drug demonstrated statistically significant improvements in PGI-S scores and viral load reduction, indicating other positive efficacy signals.
Despite the primary endpoint miss, Enanta's Chief Medical Officer stated that advancement to Phase III trials is justified by the Phase IIb data. Zelicapavir has also received Fast Track designation from the U.S. Food and Drug Administration (FDA), supporting its expedited development.
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