ALY-101 / Alys Pharma - LARVOL DELTA

Alys Pharmaceuticals Announces Dosing of First Patient in Phase IIa Trial of ALY-101 for Alopecia Areata (PRNewswire) - "Alys Pharmaceuticals...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....The Phase IIa trial will investigate if ALY-101 is safe and well tolerated following injections in the scalp in subjects with alopecia areata randomly vs. placebo every 4 weeks for a treatment period of 8 weeks. The study is expected to be completed in 2026."

P2a data • Trial status • Alopecia

Alys Pharmaceuticals receives IND clearance for Phase 2a trial of first genetic medicine program in dermatology (PRNewswire) - "Alys Pharmaceuticals, Inc...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...The Company remains on track to deliver multiple clinical Proof-of-Concept (POC) readouts by 2027."

IND • Alopecia