Salute e Benessere
Alys Pharmaceuticals announces CTA submission for ALY-301, the first mast cell selective c-Kit inhibitor for treatment of Cold Urticaria
ALY-301 is the first mast cell-selective c-Kit inhibitor to enter the clinic. It is a cis-targeting bispecific antibody binding c-Kit and CD-203c, allowing selective targeting and depletion of mast cells over other c-Kit positive cells. This differentiated profile of ALY-301 is expected to offer a significantly improved safety profile over conventional c-Kit targeting agents and enable safe, chronic dosing in multiple mast-cell dependent diseases such as Chronic Urticaria.
The trial will evaluate the safety and efficacy of ALY-301 at multiple sites across Germany . This CTA submission is the first clinical program to emerge from Alys' Granular platform, which is focused on the precise targeting of mast cell biology through advanced antibody engineering.
This study marks the second major clinical milestone for Alys Pharmaceuticals. 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 (LMU, Munich ), Craig Mello (UMass Chan Medical School), Eric Deutsch ( Gustave Roussy ) 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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