ALY-301 / Alys Pharma - LARVOL DELTA

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 (PRNewswire) - "Multicenter Phase 1/1b study to enroll both healthy volunteers and patients with Cold Urticaria with initial data readouts expected in 2026."

P1 data • Trial status • Urticaria

Molecular Design & Characterization of GTX-B001: A Bispecific Antibody targeting c-Kit/CD203c for Selective Mast Cell Silencing (EADV 2025) - "We sought to engineer a bispecific antibody, GTX-B001 (ALY-301), that targets c-Kit selectively in mast cells to maintain efficacy while improving the safety profile to enable chronic dosing for chronic inflammatory disease...Conclusion These studies provide evidence that GTX-B001 is an effective MC-selective agent with demonstrated co-operative binding only to cells that express both c-Kit and CD203c targets. This has the potential for safe and potent mast cell targeting without global c-Kit targeting side effects and enables chronic dosing in chronic inflammatory disease settings."

Late-breaking abstract • Dermatology • Hematological Disorders • Immunology • Inflammation • Neutropenia • Urticaria • KIT

CHILL-MC: A Phase 1 Study of GTX-B001 in Healthy Subjets and Patients With Cold Urticaria (clinicaltrials.gov) - P1 | N=72 | Not yet recruiting | Sponsor: Granular Therapeutics Limited

New P1 trial • Dermatology • Immunology • Urticaria