Enanta Pharmaceuticals has announced the first participant enrollment in a Phase 1 clinical trial of EDP-978, an oral, once-daily KIT inhibitor being developed to treat chronic urticaria and other mast cell-driven diseases. Topline data from the trial is expected in the fourth quarter of this year.
The randomized, double-blind, placebo-controlled first-in-human trial will enroll approximately 98 healthy adult volunteers ranging in age from 18 to 65 years old. The study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of EDP-978, including effects on biomarkers such as serum tryptase, which will provide insight into the drug’s activity.
According to the company, chronic urticaria is a mast cell-driven skin disorder characterized by spontaneous or inducible wheals (hives), angioedema, or both persisting for six weeks or longer. The condition 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 specific stimuli such as cold, pressure, cholinergic activity, or sunlight. The disease course can be prolonged, with some subtypes persisting for years. CSU is unpredictable, with spontaneous remissions and relapses.
The severe impact of chronic urticaria on patients’ lives is significant. Intense itching, sleep disturbance, and visible lesions cause considerable distress. Loss of work productivity, anxiety, and depression are common consequences. Up to one third of patients with CIndU may also have concurrent CSU, and many patients are refractory to currently approved therapies.
EDP-978 is described as a potent and selective KIT inhibitor demonstrating nanomolar potency in binding and cellular assays, sub-nanomolar activity in vivo, and high selectivity for KIT versus other kinases. The compound also exhibits favorable in vitro and in vivo ADME properties preclinically. Beyond chronic urticaria, the company is also developing other programs targeting the type 2 immune response.
This article is an AI-assisted summary. All facts and figures are drawn from the original report: https://www.biospace.com/press-releases/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