US-based immuno-dermatology company Alys Pharmaceuticals has received clearance from the US Food and Drug Administration (FDA) and Health Canada for a Phase IIa trial of ALY-101 for alopaecia areata (AA).
The trial will assess ALY-101’s efficacy and safety across five sites in the US and Canada.
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It is the first clinical study of a drug candidate in the company’s pipeline, which includes assets that target conditions such as chronic spontaneous urticaria, vitiligo, systemic mastocytosis and atopic dermatitis.
Alys Pharmaceuticals expects to deliver the multiple clinical proof-of-concept readouts from the trial by 2027.
AA is an autoimmune disease that causes hair loss by attacking the body’s hair follicles, often leading to diminished quality of life and psychological distress.
With present treatments considered inadequate, the worldwide AA market is expected to be worth several billion US dollars in the next 5-10 years.
Alys Pharmaceuticals co-founder and chief operating officer Thibaud Portal said: “This milestone is a pivotal moment in our journey to bring innovative dermatology treatments to patients.
“Not only does it underscore the potential of ALY-101, but also our ambition to establish siRNA as a transformative, long acting therapeutic class in dermatology.
“Additionally, it highlights the preparedness of Alys to advance the other programs from our pipeline, including our mastocyte-selective bispecific antibody therapy for chronic urticaria which is next on the docket.”
Based in Massachusetts, Alys Pharmaceuticals is a specialised immuno-dermatology company that develops treatments for several dermatological indications.
The company is supported by a $100m investment from investment firm Medicxi and was formed by merging six Medicxi companies.
It is currently progressing with mastocyte-selective therapies developed by Granular Therapeutics, one of the Medicxi companies merged to form Alys Pharmaceuticals.
Alys expects to submit clinical trial applications and investigational new drug applications for these therapies to the FDA this year.
