WAYNE, PA — Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company developing a pipeline of novel drug candidates for immuno-inflammatory diseases, announced that it has submitted an Investigational New Drug (IND) Application to the U.S. Food and Drug Administration (FDA) for ATI-1777, an investigational topical “soft” Janus kinase (JAK) 1/3 inhibitor, for the treatment of moderate to severe atopic dermatitis (AD). ATI-1777 is another compound generated from the Aclaris KINect™ drug discovery platform, and was specifically developed as a topical “soft” drug.
“We are very pleased to have achieved another development milestone with the submission of this IND and look forward to exploring the therapeutic potential of ATI-1777 in patients with moderate to severe AD,” said Dr. David Gordon, Chief Medical Officer of Aclaris. “ATI-1777 is designed to be active in the skin but rapidly metabolized in the systemic circulation, with the goal of developing a medicine that is efficacious in the treatment of AD while limiting systemic exposure.”
If the IND is allowed, Aclaris plans to initiate a Phase 1/2a multicenter, randomized, double-blind, vehicle-controlled trial to investigate the safety, tolerability, pharmacokinetics, and efficacy of topically applied ATI-1777 in subjects with moderate to severe AD in the second half of 2020. The primary endpoint will assess efficacy at 4 weeks.
ATI-1777 is an investigational topical “soft” Janus kinase (JAK) 1/3 inhibitor. “Soft” JAK inhibitors are designed to provide JAK inhibition at the site of application and be rapidly metabolized in the systemic circulation. Aclaris plans to develop ATI-1777 as an emollient-containing spray formulation. If the IND is allowed, Aclaris plans to develop ATI-1777 as a potential treatment for moderate to severe atopic dermatitis.
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