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

Professor Martin Metz, Professor of Dermatology at the Institute of Allergology at the Charité – Universitätsmedizin Berlin & Fraunhofer Institute for Translational Medicine and Pharmacology, Allergology and Immunology and Principal Investigator for ALY-301, commented: "Chronic Urticaria is a disease where the burden on patients is often underestimated. ALY-301's ability to selectively target and deplete mast cells over other c-Kit positive cells, while potentially matching the efficacy of reference c-Kit inhibitors, gives it one of the most exciting profiles I have come across, highlighting the transformative potential of precision-targeted therapies in the immune-dermatology space."

BOSTON, 30/10/2025 (informazione.news - comunicati stampa - salute e benessere)

 

 

 

ALY-301 is a first-in-class cis-targeting bispecific antibody designed to selectively deplete mast cells by binding both c-Kit and CD203c. This differentiated profile of ALY-301 is expected to enable chronic dosing in mast cell dependent diseases such as Chronic Urticaria, while avoiding the safety limitations of conventional c-Kit inhibitors.

The trial (NCT07181369) is a randomized, double-blind, placebo-controlled Phase 1/ 1b study designed to evaluate the safety, tolerability and pharmacology of ALY-301 in healthy volunteers and patients with Cold Urticaria who remain symptomatic despite antihistamines. The trial will also assess preliminary signs of efficacy in patients. The first patient has been dosed at Charité–Universitätsmedizin Berlin , with planned expansion to additional sites across Germany in the coming months following the successful outcome of the Clinical Trial Application (CTA) submitted in June 2025 .

This study is the second clinical program initiated by Alys in 2025 and the first clinical trial from the Company's Granular platform. The Alys pipeline includes a diverse portfolio of assets targeting unmet needs in indications such as atopic dermatitis, chronic spontaneous urticaria, vitiligo, and systemic mastocytosis. The Company remains on track to deliver multiple clinical Proof-of-Concept (POC) readouts by 2027.

Alys Pharmaceuticals, Inc. ("Alys") is a Boston and Lausanne-based cutting edge pure-play immuno-dermatology company. Alys is backed by international investment firm Medicxi with $100M financing. Alys has a world class leadership team that brings together experts across dermatology and advanced scientific fields, including co-founders John Harris (UMass Chan Medical School), Brian Kim (Icahn School of Medicine at Mount Sinai), Lars French , Craig Mello (UMass Chan Medical School) and Mark Prausnitz ( Georgia Institute of Technology ). Alys is led by dermatology specialist, co-founder, and COO Thibaud Portal . 

Its pipeline includes programs targeting multiple dermatological indications, including atopic dermatitis, vitiligo, chronic urticaria, psoriasis and mastocytosis. The Company entered the clinic in Q1 2025 with the siRNA platform developed by its affiliate Aldena Therapeutics, which offers the potential for long-lasting treatments that could transform the dermatology treatment landscape and is now advancing its mastocyte-selective therapies developed by affiliate Granular Therapeutics.

For further information, please visit www.alyspharma.com.

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