#Germany #Berlin #Alys Pharmaceuticals #c-Kit inhibitor #Cold Urticaria

Alys Pharmaceuticals Advances ALY-301 for Cold Urticaria Treatment

Alys Pharmaceuticals, Inc., a Boston and Lausanne-based company focusing on immune-dermatology, recently made headlines by submitting a Clinical Trial Application (CTA) to Germany's Paul-Ehrlich-Institut (PEI). This move is aimed at initiating a Phase 1/1b clinical study of ALY-301, designed to treat Cold Urticaria—a chronic skin condition characterized by the eruption of itchy, red hives upon skin exposure to cold temperatures.

Understanding Cold Urticaria

Cold Urticaria is a subtype of Chronic Inducible Urticaria (CIndU), representing a significant unmet need as current treatments often fail to adequately address symptom relief or quality of life improvements. The current market for treatments in this area is projected to grow considerably in the coming years, potentially reaching multiple billions of dollars.

The Innovation Behind ALY-301

ALY-301 is notable for being the first mast cell-selective c-Kit inhibitor to enter clinical trials. This innovative therapy employs a unique bispecific antibody, selectively targeting c-Kit and CD-203c to specifically deplete mast cells while sparing other c-Kit positive cells. This specificity is expected to markedly enhance safety, making it more suitable for chronic use in managing various mast cell-related diseases such as Chronic Urticaria.

The trial, which will include healthy volunteers as well as patients suffering from Cold Urticaria, is set to evaluate ALY-301's safety and efficacy at multiple sites across Germany. This submission marks a significant milestone as the first clinical program born from Alys's Granular platform, which emphasizes the precise targeting of mast cell biology through advanced antibody engineering.

Insights from Experts

Professor Brian Kim, a prominent figure in dermatology at the Icahn School of Medicine and Chairman of Alys's Scientific Advisory Board, expressed optimism regarding the scope of ALY-301. He stated, "ALY-301 offers a truly differentiated approach. It is the only c-Kit antibody designed to target activated mast cells while avoiding off-target effects. Unleashing the proven efficacy of c-Kit inhibition on mast cells, while sparing other cell types known to cause significant side effects, will undoubtedly lead to a transformative drug profile."

Furthermore, Professor Martin Metz from Charité – Universitätsmedizin Berlin reaffirmed the potential benefits of ALY-301, explaining that all non-clinical studies support the aim of enabling safe and effective chronic dosing of a c-Kit inhibitor through its mast cell selectivity. He expressed excitement about commencing the clinical journey and the promising outcomes anticipated for Urticaria patients.

A New Era for Allergy Treatment

Thibaud Portal, Alys's Co-Founder and COO, highlighted that increasing attention has been placed on addressing Urticaria and other allergic diseases. He pointed out that while the potency of c-Kit inhibition is well-documented, previous approaches have often been hampered by safety concerns linked to indiscriminate c-Kit targeting. ALY-301 represents a groundbreaking strategy that couples the powerful mechanism of c-Kit inhibition with selectivity and increased safety.

This study not only marks the second major clinical milestone for Alys Pharmaceuticals but also opens doors to a diverse pipeline aimed at treating further dermatological conditions. As the company gears up to deliver multiple Proof-of-Concept readouts by 2027, the expectations surrounding ALY-301 signal a pivotal moment in the quest for novel therapies in dermatology.

About Alys Pharmaceuticals

Alys Pharmaceuticals, Inc. specializes in cutting-edge immuno-dermatological treatments and is backed by the international investment firm Medicxi. The company is led by a distinguished team of experts in dermatology, with a lineup of programs aimed at various dermatological indications, including atopic dermatitis, chronic urticaria, and more. As part of their commitment to innovation, Alys is actively developing therapies that promise to transform the landscape of dermatological treatment.

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