Immune-dermatology focused company Alys Pharmaceuticals Inc announced on Tuesday that the US Food and Drug Administration (FDA) and Health Canada have approved 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 is intended to assess the safety and efficacy of the product, an intradermal injectable JAK1 siRNA-lipid conjugate, at five sites across the United States and Canada.

This is the first clinical study from the Alys pipeline, which includes a wide range of assets targeting unmet needs in indications such as atopic dermatitis, chronic spontaneous urticaria, vitiligo and systemic mastocytosis. The company said that it is on track to deliver multiple clinical Proof-of-Concept (POC) readouts by 2027.

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.