Alys Pharmaceuticals announces CTA submission for ALY-301, the first mast cell selective c-Kit inhibitor for treatment of Cold Urticaria
- ALY-301 is a first-in-class bispecific antibody targeting c-Kit and CD-203c with mast cell selectivity
- Designed to enable safe dosing in chronic conditions and deliver clinical proof-of concept in a Phase 1/1b study
Boston, Massachusetts and Lausanne, Switzerland, 10 June 2025 – Alys Pharmaceuticals, Inc. (“Alys”), an immune-dermatology focused company, today announces the submission of a Clinical Trial Application (CTA) to Germany’s Paul-Ehrlich-Institut (PEI) to initiate a Phase 1/1b study of ALY-301 in healthy volunteers and patients suffering from Cold Urticaria, a subtype of Chronic Inducible Urticaria (CIndU).
