Alys Pharmaceuticals Announces Dosing of First Patient in Phase IIa Trial of ALY-101 for Alopecia Areata
- Unique siRNA platform, developed with Nobel Prize Laureate Craig Mello, offers potential for treating multiple dermatology indications
- ALY-101 is formulated as an intradermal injectable for the treatment of Alopecia Areata
- Health Authorities in Canada and the United States provided swift CTA & IND approval allowing for efficient dosing of the first patients
Excerpt from the Press Release:
BOSTON and LAUSANNE, Switzerland, March 27, 2025 /PRNewswire/ — Alys Pharmaceuticals, Inc. (“Alys”), an immune-dermatology focused company, today announces that the first patient has been dosed in its Phase IIa trial of ALY-101 in patients suffering from Alopecia Areata (AA), a chronic autoimmune disease with significant unmet medical need that often leads to significant psychological distress and a reduced quality of life.
ALY-101 is the first clinical candidate from Alys’s pipeline of siRNA molecules developed for dermatological applications. ALY-101 is designed for local and selective modulation of inflammation and targets JAK1, a key driver of alopecia areata, with a JAK1-targeting siRNA-lipid conjugate. For the initial indication, it is formulated as an intradermal injectable. Alys is also developing a trans-epidermal formulation of ALY-101, for the treatment of indications such as atopic dermatitis and vitiligo, which should reach clinical stage in 2026.
Craig Mello, PhD, 2006 Nobel Prize in Physiology or Medicine Laureate, the Blais University Chair in Molecular Medicine and distinguished Professor of RNA therapeutics at UMass Chan Medical School, said: “It is exciting to see siRNA from our unique platform at the RNA Therapeutic Institute at UMass Chan Medical School, being deployed to yet another new organ system. Thanks to the unique accessibility of skin, we believe siRNA can result in a step change innovation in dermatological indications.”
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