Alys Pharmaceuticals gets IND clearance for Phase 2a dermatology genetic medicine trial

Alys Pharmaceuticals, an innovative company focused on immune-dermatology, has announced significant advancements in its pipeline following a substantial $100 million seed investment from Medicxi. The company, based in Boston and Lausanne, is pioneering novel treatments for dermatological conditions, with its first clinical candidate, ALY-101, receiving clearance from both the U.S. Food and Drug Administration (FDA) and Health Canada for clinical trials.

ALY-101 is an intradermal injectable JAK1 siRNA-lipid conjugate designed to treat Alopecia Areata (AA), a chronic autoimmune condition that frequently leads to severe psychological distress and diminished quality of life. The current treatment options for AA are considered insufficient, and the global market for AA therapies is expected to expand significantly in the coming years. The Phase 2a trial of ALY-101 will assess its safety and efficacy at five locations across the United States and Canada.

This clinical trial is the first from Alys's robust pipeline, which encompasses a range of potential solutions for unmet medical needs in conditions such as atopic dermatitis, chronic spontaneous urticaria, vitiligo, and systemic mastocytosis. The company has set an ambitious goal to deliver multiple clinical Proof-of-Concept (POC) results by 2027, aiming to transform the treatment landscape across various dermatological diseases.

Professor Lars French, Acting Chief Medical Officer at Alys Pharmaceuticals and a prominent figure in dermatology, highlighted the transformative potential of ALY-101. He emphasized how the long-lasting effects of the siRNA technology employed could revolutionize treatment options for patients with Alopecia Areata through its infrequent injection regimen.

ALY-101 is the outcome of a long-term research collaboration between Alys and the RNA Institute of UMass Chan Medical School, targeting the development of siRNA therapies for dermatological applications. Professor John Harris, Chief Innovation Officer at Alys Pharmaceuticals and Chair of Dermatology at UMass Chan Medical School, expressed enthusiasm about the progress of ALY-101. He underscored the company's commitment to advancing siRNA technology for inflammatory skin diseases and highlighted the potential for further developments in the pipeline.

Thibaud Portal, Co-Founder and Chief Operating Officer of Alys Pharmaceuticals, sees this milestone as a critical step in the company's mission to deliver cutting-edge dermatology treatments. He stated that this accomplishment not only demonstrates the potential of ALY-101 but also underscores Alys's ambition to establish siRNA as a groundbreaking therapeutic class in dermatology. Additionally, Portal pointed to the readiness of Alys to advance other promising programs, including a mastocyte-selective bispecific antibody therapy for chronic urticaria.

Alys Pharmaceuticals is a cutting-edge company that specializes in immuno-dermatology and has been supported by a $100 million investment from Medicxi. The company's leadership team is comprised of renowned experts from the fields of dermatology and advanced sciences, including co-founders John Harris, Brian Kim, Lars French, Craig Mello, Eric Deutsch, and Mark Prausnitz. Alys was formed from the merger of six asset-centric companies under Medicxi and is entering the clinical stage with a promising siRNA platform developed by Aldena Therapeutics. This platform holds the potential for long-lasting treatments that could significantly impact the dermatology field. Additionally, Alys is progressing with the development of mastocyte-selective therapies, with clinical applications anticipated by 2025.