Aclaris Therapeutics, the Wayne, Pennsylvania-based clinical-stage biopharmaceutical company, has received FDA Fast Track Designation for modzatinib (ATI-2138) to treat moderate to severe lichen planus, including the oral erosive, cutaneous, and lichen planopilaris forms of the disease. Fast Track status is designed to speed up development and review for treatments addressing serious conditions with unmet medical need, giving Aclaris more frequent access to FDA feedback, the ability to submit its eventual approval application in sections rather than all at once, and potential eligibility for Priority Review down the line.
A Disease With Zero Approved Treatments
Lichen planus is a chronic inflammatory skin and mucosal condition, and as Aclaris points out, there is currently no FDA-approved therapy for it at all, patients and physicians manage it with off-label options instead. Chief Medical Officer Dr. Jesse Hall described the designation as validation of a real gap in care: “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. 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.” That characterization lines up with independent dermatology coverage of the condition, which has separately flagged the lack of approved options and the reliance on off-label treatment as an ongoing clinical problem.
What Modzatinib Actually Targets
Modzatinib works as a dual inhibitor of interleukin-2-inducible T cell kinase (ITK) and Janus kinase 3 (JAK3), a combination Aclaris says lets it suppress the disease-driving T cells behind lichen planus through two separate pathways at once, both T cell receptor signaling and the cytokine activation that follows it. The company selected lichen planus as modzatinib’s lead indication earlier this year, arguing the drug’s dual mechanism is a particularly close fit for a disease it describes as CD8+/Th1-driven interface dermatitis. That decision was backed by preclinical results in animal models of inflammation and autoimmune disease, along with a favorable safety and pharmacokinetic profile from earlier human studies, including a Phase 2a trial of the compound in atopic dermatitis.
What Comes Next
Aclaris expects to begin a phased, multi-part Phase 2b trial of modzatinib in lichen planus during the fourth quarter of 2026. Fast Track designation doesn’t change the clinical bar the drug has to clear, but it does give Aclaris a more direct line to FDA reviewers as that trial gets underway, a meaningful advantage for a Wayne-based company trying to bring the first approved lichen planus treatment to market rather than competing against an established field.
