FDA grants fast track status to Aclaris drug for lichen planus

Aclaris Therapeutics, Inc. (NASDAQ: ACRS) announced that the U.S. Food and Drug Administration has granted Fast Track Designation for its drug candidate modzatinib (ATI-2138) for the treatment of moderate to severe lichen planus (LP), including oral erosive LP, cutaneous LP, and lichen planopilaris.

The designation covers a condition for which no therapies are currently approved. Fast Track status is intended to facilitate development and expedite review of therapies that treat serious conditions and address unmet medical needs. It allows for more frequent interactions with the FDA on development plans and clinical trial design, and permits rolling review of a New Drug Application, meaning completed sections can be submitted and reviewed on an ongoing basis.

Aclaris said it expects to initiate a phased multi-part Phase 2b trial of modzatinib in LP in the fourth quarter of 2026.

"Lichen planus is a serious, clinically concerning disease with debilitating symptoms that can affect the quality of life of patients suffering from this disorder; unfortunately, there are currently no approved therapies," said Dr. Jesse Hall, Chief Medical Officer of Aclaris. "This is an important milestone for our company; we look forward to more frequent interactions with the FDA as we move modzatinib into a Phase 2b trial later this year."

Programs with Fast Track designation may also be eligible for Priority Review if relevant criteria are met. The information is based on a press release issued by Aclaris Therapeutics.

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