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Enanta Pharmaceuticals Announces First Participant Dosed in Phase 1 Clinical Trial of EDP-978, an Oral, Once-Daily KIT Inhibitor, in Development for the Treatment of Urticaria
Phase 1 Study Will Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of EDP-978 in Healthy Volunteers Topline Data Expected in Q4 2026
About this update from Enanta Pharmaceuticals, Inc.
[{"type":"text","content":"\n\nPhase 1 Study Will Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of EDP-978 in Healthy Volunteers\n\n\n\nTopline Data Expected in Q4 2026\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 viral infections and immunological diseases today announced that the first participant has been dosed in a Phase 1 clinical trial of EDP-978, an oral, once-daily KIT inhibitor in development for urticaria and other mast cell-driven diseases. The Phase 1 single-ascending dose (SAD) and multiple-ascending dose (MAD) clinical trial will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of EDP-978 in healthy adult volunteers.\n\n\n“We are excited to move our lead immunology program into clinical development with this Phase 1 study of EDP-978, a potent and selective once-daily KIT inhibitor in development for the treatment of chronic urticaria and potentially other mast cell-mediated diseases,” said Scott T. Rottinghaus, M.D., Chief Medical Officer of Enanta Pharmaceuticals. “These severely debilitating inflammatory skin diseases result in itchy, red hives and angioedema that can significantly impact a patient’s quality-of-life, causing sleep disturbance, fatigue, irritability, anxiety, and depression. Many patients are refractory to currently approved therapies, creating an unmet medical need for a new efficacious oral agent. We look forward to reporting topline Phase 1 data in the fourth quarter of this year, including effects on biomarkers such as serum tryptase, which will give us insight into the activity of EDP-978.”\n\n\nThe randomized, double-blind, placebo-controlled, first-in-human Phase 1 clinical trial is expected to enroll approximately 98 healthy adult volunteers ranging in age from 18 to 65 years old to evaluate the safety, tolerability, PK, and PD (including serum tryptase) of EDP-978. The study includes a SAD phase, with a two-part food-effect (FE) cohort, and a MAD phase with a 14-day treatment period.\n\n\nAbout EDP-978\n\n\nEDP-978 is a novel, potent and selective oral KIT inhibitor in development for the treatment of chronic urticaria and potentially other mast cell driven diseases. EDP-978 demonstrates nanomolar potency in both binding and cellul...