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Enanta Pharmaceuticals Doses First Subject in a Phase 1 Clinical Study of EDP-323, its Novel, Oral L-Protein Inhibitor in Development for the Treatment Respiratory Syncytial Virus
WATERTOWN, Mass.--(BUSINESS WIRE)-- Enanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule
About this update from Enanta Pharmaceuticals, Inc.
[{"type":"text","content":" WATERTOWN, Mass.--(BUSINESS WIRE)--\nEnanta Pharmaceuticals, Inc. (NASDAQ:ENTA), a clinical-stage biotechnology company dedicated to creating small molecule drugs for viral infections and liver diseases, today announced that it has dosed the first subject in its Phase 1 clinical trial of EDP-323, a novel, oral L-protein inhibitor in development for the treatment of respiratory syncytial virus (RSV).\n\n“This first-in-human study of EDP-323, our selective, direct-acting antiviral specifically targeting the RSV L-protein, is an important milestone for Enanta as we mark the continued expansion of our clinical RSV portfolio. Compelling preclinical data show that EDP-323 potently blocks RSV replication and pathology across all RSV genotypes positioning EDP-323 as a potentially best-in-class potent oral antiviral treatment for RSV,” said Scott T. Rottinghaus, M.D., Senior Vice President and Chief Medical Officer of Enanta Pharmaceuticals. “EDP-323 could be used as a monotherapy or in combination with other RSV mechanisms, such as EDP-938, to broaden the addressable patient populations or treatment windows. As we continue to build upon our leadership in the RSV space, we believe having two unique mechanisms to treat the virus could potentially provide additional benefit to patients.”\n\nThis randomized, double-blind, placebo-controlled, first-in-human Phase 1 study will enroll approximately 80 healthy subjects ranging in age from 18 to 65 years old to evaluate the safety, tolerability and pharmacokinetics of EDP-323 with a single-ascending dose (SAD) phase, including a two-part food-effect (FE) cohort, and a multiple-ascending dose (MAD) phase. All SAD and MAD cohorts will enroll eight participants who will be randomized to receive EDP-323 or placebo in a 3:1 ratio. The SAD/FE cohort will enroll 10 subjects randomized in a 4:1 ratio.\n\nEDP-323 is supported by in vitro data demonstrating a significant reduction in RSV replication with picomolar potency in primary human bronchial epithelial cells against RSV A and B, with consistent potency across a range of RSV clinical isolates in various cell types. In a mouse model of RSV infection, EDP-323 treatment was associated with dose-dependent decreases in viral load in the lung, reduced lung immunopathology and decreases in pro-inflammatory cytokines, including IFNγ, TNFα, and IL1β. Additi...