Alys Pharmaceuticals Begins Phase IIa Trial Dosing of ALY-101 for Alopecia Areata

Alys Pharmaceuticals, Inc. has announced a significant advancement in the treatment of Alopecia Areata (AA), a chronic autoimmune condition that often causes psychological distress due to its impact on appearance and quality of life. The first patient has recently been administered with ALY-101 in a Phase IIa clinical trial, marking a pivotal moment for the company and its ongoing research.

ALY-101 emerges as the inaugural clinical candidate from Alys's line of siRNA molecules, specifically developed for dermatological use. This therapeutic agent targets JAK1, a key element in the pathology of alopecia areata, through a JAK1-targeting siRNA-lipid conjugate. For its initial application, ALY-101 is available as an intradermal injection. The company is also working on a trans-epidermal version of ALY-101, aimed at treating other skin conditions like atopic dermatitis and vitiligo, with clinical trials slated for 2026.

Craig Mello, a distinguished figure in the field of RNA therapeutics and a Nobel Laureate, highlighted the innovation brought by the siRNA platform developed at UMass Chan Medical School. He expressed optimism about the potential of siRNA therapies, noting their significant role in addressing dermatological diseases due to the skin’s unique accessibility.

Anastasia Khvorova, a leading researcher in RNA therapeutics, emphasized the precision and safety of ALY-101, pointing out its enhanced specificity and stability. By minimizing systemic exposure, ALY-101 promises broad clinical applications while maintaining patient safety.

Lars French, Alys Pharmaceuticals’ Acting Chief Medical Officer, expressed enthusiasm for ALY-101’s progress and potential. He noted the positive feedback from clinical sites specializing in Alopecia Areata, indicating the treatment’s promise of long-lasting effectiveness and reduced frequency of injections.

The Phase IIa trial aims to evaluate the safety and tolerability of ALY-101 in patients with Alopecia Areata. Participants will receive injections in the scalp every four weeks over an eight-week period. The trial is scheduled for completion in 2026, with further clinical outcomes anticipated by 2027.

Alys Pharmaceuticals is at the forefront of immuno-dermatology, headquartered in Boston and Lausanne. Supported by the international investment firm Medicxi, Alys benefits from a $100M financing, enabling it to drive forward its innovative pipeline. The company’s leadership comprises experts from renowned institutions worldwide, spearheading transformative approaches in skin disease therapies.

Formed from the merger of six specialized entities — Aldena Therapeutics, Graegis Pharmaceuticals, Granular Therapeutics, Klirna Biotech, Nira Biosciences, and Vimela Therapeutics — Alys is poised to make significant strides in dermatological treatments. Its efforts include developing therapies for various skin conditions, with an eye toward introducing long-lasting solutions grounded in advanced siRNA technology.

In addition to its work on ALY-101, Alys is progressing with mastocyte-selective therapies, with regulatory submissions anticipated in 2025. These initiatives reflect Alys’s commitment to reshaping the dermatology landscape through cutting-edge scientific advancements and a focus on unmet clinical needs.