Regenerative Medicine Designation for Alzheimer’s Therapy

FDA has granted Longeveron a Regenerative Medicine Advanced Therapy (RMAT) designation for Lomecel-B and its use for treating mild Alzheimer’s Disease. The allogeneic cellular investigational therapy is currently being evaluated across multiple indications, including Alzheimer’s (Phase 2a completed), aging-related frailty (Phase 2b completed) and hypoplastic left heart syndrome  (Phase 2b ongoing). The designation is based on data from the CLEAR MIND Phase 2a clinical trial and additional clinical data and imaging biomarker results. Full study results for CLEAR MIND will be reported 7/28 at the 2024 Alzheimer’s Association International Conference.

The company says the RMAT designation is the fourth special regulatory designation received for Lomecel-B. Previously, the therapy was granted an Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation.