Aclaris Therapeutics Receives FDA Fast Track Designation for Modzatinib in Moderate to Severe Lichen Planus
核心洞察
The FDA has granted Fast Track designation to Aclaris Therapeutics (搜索)' modzatinib (搜索) (ATI-2138) for moderate to severe lichen planus (搜索), including oral erosive LP, cutaneous LP, and lichen planopilaris.
Lichen planus (搜索) is a serious immuno-inflammatory disease with debilitating symptoms and no currently approved therapies, representing a significant unmet medical need.
Aclaris expects to initiate a phased multi-part Phase 2b clinical trial of modzatinib (搜索) in lichen planus (搜索) during the fourth quarter of 2026.
WAYNE, Pa. — Aclaris Therapeutics (搜索), Inc. (NASDAQ: ACRS) announced on August 6, 2026, that the U.S. Food and Drug Administration has granted Fast Track designation for modzatinib (搜索) (ATI-2138), an investigational therapy for moderate to severe lichen planus (搜索) (LP). The designation covers the full spectrum of the disease, including oral erosive LP, cutaneous LP, and lichen planopilaris.
The clinical-stage biopharmaceutical company, which focuses on developing novel product candidates for immuno-inflammatory diseases, also confirmed plans to initiate a phased multi-part Phase 2b trial of modzatinib (搜索) in lichen planus (搜索) in the fourth quarter of 2026.
An Unmet Medical Need
Lichen planus (搜索) is a chronic inflammatory condition that can cause significant morbidity across multiple body sites. Patients may experience painful oral erosions, disfiguring skin lesions, and scarring hair loss, all of which can profoundly impact quality of life. Despite the disease burden, no therapies are currently approved by the FDA for the treatment of lichen planus.
"Lichen planus (搜索) 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 (搜索) into a Phase 2b trial later this year."
Fast Track Designation Benefits
The FDA's Fast Track designation is designed to facilitate the development and expedite the review of investigational therapies that treat serious conditions and fill an unmet medical need. For Aclaris, the designation carries several practical advantages. It provides for more frequent interactions with the FDA regarding the development plan and clinical trial design, supporting a potentially more efficient path to registration.
Additionally, Fast Track designation allows for rolling review of a New Drug Application (NDA), meaning completed sections may be submitted and reviewed on an ongoing basis rather than requiring the entire application to be completed before review begins. Fast Track-designated programs may also be eligible for Priority Review if relevant criteria are met, which could further accelerate the regulatory timeline.
Next Steps for Modzatinib (搜索)
With the Fast Track designation secured, Aclaris is preparing to advance modzatinib (搜索) into a phased, multi-part Phase 2b clinical trial in patients with lichen planus (搜索). The trial is expected to commence in the fourth quarter of 2026. Further details regarding trial design, endpoints, and patient enrollment criteria have not yet been disclosed.
Aclaris Therapeutics (搜索) maintains a multi-stage portfolio of product candidates targeting immuno-inflammatory diseases where patients lack satisfactory treatment options. The company's pipeline is supported by an internal R&D engine focused on addressing areas of significant unmet medical need.