Alys Pharmaceuticals doses first subject in Phase 1/1b trial of ALY-301, a first-in-class mast cell selective c-Kit inhibitor for Chronic Urticaria
- Differentiated profile of ALY-301 designed to enable chronic dosing in mast cell dependent diseases while avoiding the safety limitations of conventional c-Kit inhibitors
- Multicenter Phase 1/1b study to enroll both healthy volunteers and patients with Cold Urticaria with initial data readouts expected in 2026
Boston, Massachusetts and Lausanne, Switzerland, 30 October 2025 – Alys Pharmaceuticals, Inc. (“Alys”), an immune-dermatology focused company, today announces that the first subject has been dosed in a Phase 1/1b study of ALY-301, a first-in-class mast cell selective c-Kit inhibitor for the treatment of Cold Urticaria, a subtype of Chronic Inducible Urticaria (CIndU) that is also considered to be a good model for the broader Chronic Urticaria population.
