Longeveron® Announces Nature Medicine Publication of Results of Phase 2a Clinical Trial Evaluating Laromestrocel (Lomecel-B™) in Alzheimer’s Disease

Core Insights - Longeveron Inc. announced the publication of results from the CLEAR MIND Phase 2a clinical trial for laromestrocel (Lomecel-B™) as a potential treatment for mild Alzheimer's disease, reinforcing its safety and efficacy [2][3] - The trial involved 48 patients aged 60-85, with results indicating improvements in cognitive function, quality of life, and brain volume [5][11] - Laromestrocel (Lomecel-B™) is the first cellular therapeutic candidate to receive U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) designation for Alzheimer's disease [5][7] Company Overview - Longeveron is a clinical stage biotechnology company focused on developing regenerative medicines to address unmet medical needs, with laromestrocel (Lomecel-B™) as its lead investigational product [9] - The company is pursuing multiple indications, including hypoplastic left heart syndrome, Alzheimer's disease, and aging-related frailty [9] Clinical Trial Details - The CLEAR MIND trial was randomized and placebo-controlled, achieving primary safety and secondary efficacy endpoints [3][6] - Key findings showed laromestrocel (Lomecel-B™) improved cognitive function and minimized brain volume loss associated with Alzheimer's disease [11] - Safety evaluations indicated that laromestrocel (Lomecel-B™) was well tolerated, with no significant adverse effects reported [6][11] Mechanism of Action - Laromestrocel (Lomecel-B™) is derived from mesenchymal stem cells (MSCs) and is believed to have multiple mechanisms of action, including anti-inflammatory and pro-vascular effects [8][9] - The therapy aims to address the underlying pathology of Alzheimer's disease without the limitations of previous treatments [3][5] Regulatory Status - The FDA has granted laromestrocel (Lomecel-B™) both RMAT and Fast Track designations, facilitating greater access to the FDA during its development [7][9] - The company plans to meet with the FDA to discuss future development paths for laromestrocel (Lomecel-B™) in Alzheimer's disease [7]