Enanta Pharmaceuticals Inc Announces First Participant Dosed in Phase 1 Clinical Trial of Edp-978

Published: 2026-04-13 14:55:34 ET ENTA

Published on 04/13/2026 at 02:55 pm EDT

Enanta Pharmaceuticals, Inc. 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. Topline data is expected in the Fourth Quarter 2026.

The 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. EDP-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 cellular assays, sub-nanomolar activity in vivo, and high selectivity for KIT versus other kinases. EDP-978 also exhibits favorable in vitro and in vivo ADME properties preclinically. Chronic urticaria is a mast-cell driven skin disorder defined by the spontaneous or inducible occurrence of wheals (hives), angioedema, or both, persisting for six weeks or longer.

It includes two main subtypes ? chronic spontaneous urticaria (CSU), where there is no consistent identifiable trigger, and chronic inducible urticaria (CIndU), where lesions are reproducibly provoked by a specific stimulus such as cold, pressure, cholinergic activity, or sunlight. CSU is unpredictable, with spontaneous remissions and relapses that can persist for months to years.

Intense pruritus, sleep disturbance, and visible lesions experienced by those living with CSU can have a significant impact on quality of life. Loss of work productivity, anxiety, and depression are part of the patient burden. CIndU can be equally burdensome as exposure to daily stimuli can result in recurrent symptoms and avoidance of behaviors that can impair quality of life.

Up to one third of patients with CIndU may also have concurrent CSU. The disease course can be prolonged, with some subtypes persisting for years.