WATERTOWN, Mass. — Enanta Pharmaceuticals has dosed the first participant in a Phase 1 clinical trial evaluating EDP-978, an oral, once-daily KIT inhibitor being developed to treat urticaria and other mast cell-driven diseases.
The early-stage trial will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of the drug in healthy adult volunteers. Topline results are expected in the fourth quarter of 2026.
“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.”
The randomized, double-blind, placebo-controlled study is expected to enroll about 98 healthy volunteers between the ages of 18 and 65. It includes both single-ascending dose and multiple-ascending dose stages, along with a food-effect cohort and a 14-day treatment period.
EDP-978 is designed to selectively inhibit KIT, a key driver of mast cell activity. The company said preclinical data show the drug has strong potency and selectivity, along with favorable absorption, distribution, metabolism, and excretion properties.
Enanta is advancing the program as part of its broader effort to develop small-molecule therapies for immunological diseases, particularly for patients who do not respond to existing treatments.
