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Aclaris Therapeutics Receives Fast Track Designation for Modzatinib (ATI-2138) for Moderate to Severe Lichen Planus (LP)

  • Aclaris Therapeutics received Fast Track Designation from the FDA for modzatinib (ATI-2138) to treat moderate to severe lichen planus, including oral erosive LP, cutaneous LP, & lichen planopilaris.
  • The company expects to initiate a phased multi-part Phase 2b trial of modzatinib for lichen planus in the fourth quarter of 2026.
  • Fast Track designation facilitates more frequent FDA interactions regarding development plans & allows for rolling review of New Drug Applications.
  • Lichen planus is described as a serious condition with debilitating symptoms & currently lacks approved therapies.
  • Aclaris is a clinical-stage biopharmaceutical company developing novel product candidates for immuno-inflammatory diseases.