Alys Pharmaceuticals, Inc. (“Alys”), an immune-dermatology focused company, today announces that the U.S. Food and Drug Administration (FDA) and Health Canada have cleared the Investigational New Drug (IND) / Clinical Trial Application (CTA) for the study of ALY-101 in patients suffering from Alopecia Areata (AA).
The Phase 2a trial will evaluate the safety and efficacy of ALY-101, an intradermal injectable JAK1 siRNA-lipid conjugate, at five sites across the United States and Canada. AA is a chronic autoimmune disease that often leads to significant psychological distress and a reduced quality of life. With current treatments deemed inadequate, the global AA market is projected to reach multiple billions within the next five to ten years.
This marks the first clinical study from the Alys pipeline, which includes a broad portfolio of assets targeting unmet needs in additional indications such as atopic dermatitis, chronic spontaneous urticaria, vitiligo, or systemic mastocytosis. The Company remains on track to deliver multiple clinical Proof-of-Concept (POC) readouts by 2027.
Professor Lars French, Acting Chief Medical Officer of Alys Pharmaceuticals and Professor and Chairman of the Department of Dermatology at the Ludwig Maximilian University , commented: “With the long-acting effects inherent to our siRNA technology which allow for infrequent intradermal injections, ALY-101 has the potential to transform treatment options for patients with Alopecia Areata.”
ALY-101 is the first clinical candidate to emerge from a multi-year joint research between Alys and the RNA Institute of UMass Chan Medical School, focused on developing siRNA therapies for dermatological use.
Professor John Harris, Chief Innovation Officer of Alys Pharmaceuticals and Chair of Dermatology at UMass Chan Medical School, said: “Our goal is to pioneer the use of siRNA technology in inflammatory skin diseases, and we look forward to advancing ALY-101, alongside the other siRNA candidates targeting a range of diseases, targets, and routes of administration in the near future.”
Thibaud Portal, Co-Founder and Chief Operating Officer of Alys Pharmaceuticals, added: “This milestone is a pivotal moment in our journey to bring innovative dermatology treatments to patients. Not only does it underscore the potential of ALY-101, but also our ambition to establish siRNA as a transformative, long acting therapeutic class in dermatology. Additionally, it highlights the preparedness of Alys to advance the other programs from our pipeline, including our mastocyte-selective bispecific antibody therapy for chronic urticaria which is next on the docket.”
