Immuno-dermatology company Alys Pharmaceuticals Inc announced on Thursday that the first patient has been dosed in its Phase IIa trial of ALY-101 for Alopecia Areata (AA).
The product is the first clinical candidate from the company's range of siRNA molecules developed for dermatological applications. It is designed for local and selective modulation of inflammation, and is aimed at JAK1, a key driver of alopecia areata, with a JAK1-targeting siRNA-lipid conjugate.
ALY-101 is formulated as an intradermal injectable for the initial indication.
Alys is also developing a trans-epidermal formulation of ALY-101, for the treatment of indications such as atopic dermatitis and vitiligo, which will reach clinical stage in 2026.
The Phase IIa trial will assess if the product is safe and well tolerated subsequent to injections in the scalp in subjects with alopecia areata randomly compared to placebo every four weeks, and over a treatment period of eight weeks. The study is expected to be completed in 2026.
Vast Therapeutics' ALX1 drug candidate granted QIDP designation by US FDA
Journey Medical launches Emrosi for treatment of rosacea
Evommune enrols first patient in EVO301 Phase 2 trial
Revelation Biosciences reports Gemini's anti-inflammatory potential in PBMC study
Argent BioPharma announces positive CimetrA Phase IIb clinical trial results
Shilpa Medicare's Nor Ursodeoxycholic Acid Tablets IND receives regulatory approval in India
Gentian Diagnostics and Beckman Coulter launch calprotectin immunoassay
Kancera and Recardio sign letter of intent for licensing agreement
Dermata Therapeutics completes treatment in XYNGARI Phase 3 acne trial
GSK demonstrates significant improvement in CRSwNP treatment with depemokimab at 2025 AAAAI
AbbVie receives positive CHMP opinion for upadacitinib in giant cell arteritis
Avobis Bio LLC receives Fast Track designation from FDA for AVB-114
US FDA grants Priority Review to Sobi's sBLA for Gamifant in Still's disease-related MAS