The US Food and Drug Administration (FDA) and Health Canada have granted Investigational New Drug (IND) and Clinical Trial Application clearance, respectively, to Alys Pharmaceuticals’ phase 2a alopecia areata study.
The trial will evaluate the safety and efficacy of Alys’ intradermal injectable JAK1 siRNA-lipid conjugate, ALY-101, at five sites across the US and Canada.
Approximately 700,000 people in the US currently have some form of alopecia areata, an autoimmune disease characterised by patchy or complete hair loss on the scalp, face or other parts of the body.
Although alopecia areata can begin at any age, most patients develop the condition earlier in life, with more than 80% experiencing symptoms before the age of 40 and 40% by the age of 20.
Lars French, acting chief medical officer at Alys and professor and chairman of the department of dermatology at the Ludwig Maximilian University, said: “With the long-acting effects inherent to our siRNA technology which allow for infrequent intradermal injections, ALY-101 has the potential to transform treatment options for patients with alopecia areata.”
ALY-101 is the first clinical candidate to emerge from a multi-year joint research collaboration between Alys and the RNA Institute of UMass Chan Medical School focused on developing siRNA therapies for dermatological use.
The phase 2a trial also marks the first clinical study from Alys’ pipeline, which also includes assets targeting atopic dermatitis, chronic spontaneous urticaria, vitiligo and systemic mastocytosis.
Thibaud Portal, co-founder and chief operating officer at Alys, added: “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.”
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