Longeveron announces publication of results of Phase 2a trial of Lomecel-B

Longeveron (LGVN) announced the publication in Nature Medicine of results from the CLEAR MIND Phase 2a clinical trial evaluating laromestrocel as a potential cellular therapy for mild Alzheimer’s disease. The International Nonproprietary Names Expert Committee of the World Health Organization recently approved “laromestrocel” for the non-proprietary name of Lomecel-B. The randomized, placebo-controlled Phase 2a CLEAR MIND trial evaluated a total of 48 patients (36 were treated with laromestrocel who were 60-85 years old and had a diagnosis of mild AD in accordance with National Institutes of Health – Alzheimer’s Association criteria, a Mini-Mental State Examination score of 18-24, and a brain MRI and positron emission tomography scan consistent with AD. The clinical trial achieved its primary safety and secondary efficacy endpoints, and the study results being accepted for publication in Nature Medicine support the therapeutic potential of laromestrocel. Key findings include: The trial safety evaluations supported that laromestrocel is safe and well tolerated in the study population, in both single and multiple dosing regimens, and that patients showed no incidence of hypersensitivity, infusion-related reactions, and no cases of amyloid-related imaging abnormalities. Patients treated with laromestrocel showed an overall slowing of disease worsening compared to placebo. Positive efficacy results were demonstrated via a change from baseline at week 39 of the trial at prespecified levels using the Composite Alzheimer’s Disease Score – a secondary outcome measure that combines information across cognitive, functional capacity, and brain MRI domains. Administration of laromestrocel was associated with slowing cognitive and functional decline as demonstrated by statistically significant results in the Montreal Cognitive Assessment and statistical trending improvements compared to placebo in CDR-SB and MMSE. There was a statistically significant improvement relative to placebo observed in the Alzheimer’s Disease Cooperative Study Activities of Daily Living. Patients treated with laromestrocel showed minimized loss in brain volume in areas associated with AD, statistically significant relative to placebo. Along with positive changes in brain volumes, there was 20-30% reduction in left and right ventricular enlargement, respectively. Diffusion tensor imaging supports the concept that laromestrocel has the potential to reduce neuroinflammation compared to placebo. Laromestrocel treated patients demonstrated a numerical improvement relative to placebo in quality of life observed by caregivers and measured by the Alzheimer’s Disease Related Quality of Life and Quality of life AD scales.