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news.Aclaris Therapeutics' investigational new drug (IND) application for ATI-50001, an orally administered investigational Janus Kinase (JAK) inhibitor, for the potential treatment of alopecia totalis and alopecia universalis has cleared the 30-day review period by the US Food and Drug Administration, allowing the company to go ahead with its planned Phase 1 clinical trial
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Aclaris has initiated dosing of patients in this pharmacokinetic/pharmacodynamic (PK/PD) trial. The trial is being conducted in 12 healthy volunteers to evaluate the safety, bioavailability, and pharmacodynamics of ATI-50001.
Christopher Powala, Chief Operating Officer, said: “We are excited to have achieved this important milestone.
“We look forward to developing ATI-50001 as a potential oral treatment for these severe phenotypes of alopecia areata.”
Alopecia areata is an autoimmune disease characterized by patchy, non-scarring hair loss on the scalp and body. The scalp is the most commonly affected area, and the National Alopecia Areata Foundation estimates that 6.8 million patients in the United States have had or will develop alopecia areata during their lives.
The disease affects both women and men; two-thirds of affected individuals are younger than 30 years old at the time of onset of disease. Alopecia areata can be associated with serious psychological consequences, including anxiety and depression. A significant unmet need exists for a safe and efficacious treatment.
Aclaris has exclusively licensed several patents and patent applications involving novel selective JAK 1/3 inhibitors, including a patent portfolio from Rigel Pharmaceuticals, Inc. that covers ATI-50001 as well as ATI-50002, a topical formulation also being developed as a potential treatment for alopecia areata.
In addition, Aclaris has exclusively licensed a patent portfolio from JAKPharm and Key Organics directed to novel covalently binding, highly selective JAK 3 inhibitors.
Finally, Aclaris has exclusively licensed a patent portfolio from Columbia University directed to methods of using JAK inhibitors for the treatment of alopecia areata, androgenetic alopecia, and other dermatological conditions. This portfolio includes a recently issued U.S. patent directed to methods of treating alopecia areata, androgenetic alopecia and other hair loss disorders by administering ruxolitinib, and a recently issued patent in Japan directed to pharmaceutical compositions comprising ruxolitinib, baricitinib or other JAK inhibitors for use in treating alopecia areata, androgenetic alopecia and other hair loss disorders.