WAYNE, Pa. — Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel product candidates for immuno-inflammatory diseases, today announced that the U.S. Food and Drug Administration (the “FDA”) has granted Fast Track Designation for modzatinib (ATI-2138) for moderate to severe lichen planus (LP) including oral erosive LP, cutaneous LP, and lichen planopilaris. Aclaris expects to initiate a phased multi-part Phase 2b trial of modzatinib in LP in the fourth quarter of 2026.
Fast Track designation is intended to facilitate the development and expedite the review of investigational therapies that treat serious conditions and fill an unmet medical need. The designation provides for more frequent interactions with the FDA regarding the development plan and clinical trial design, supporting a potentially more efficient path to registration. Fast Track designation also allows for rolling review of a New Drug Application (NDA), meaning completed sections may be submitted and reviewed on an ongoing basis rather than waiting until every section of the NDA is completed before the entire application can be reviewed. Additionally, Fast Track-designated programs may also be eligible for Priority Review if relevant criteria are met. For more information on the Fast Track designation, visit the FDA’s official website.
“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.”
About Aclaris Therapeutics, Inc.
Aclaris Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing a pipeline of novel product candidates to address the needs of patients with immuno-inflammatory diseases who lack satisfactory treatment options. The company has a multi-stage portfolio of product candidates powered by a robust R&D engine. For additional information, please visit www.aclaristx.com and follow Aclaris on LinkedIn.
Aclaris Therapeutics Contact
Will Roberts
Senior Vice President
Corporate Communications and Investor Relations
(484) 329-2125
[email protected]