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.
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