Understanding the Therapeutic Potential of Lomecel-B for Alzheimer Disease: Joshua Hare, MD

WATCH TIME: 3 minutes

"First of all, lots of studies have been conducted. The side effect profile is incredibly favorable. Two, they can be infused systemically and have targeted effects. They don't need to be injected locally into affected organs, so there is no need."

At the 2024 Alzheimer’s Association International Conference (AAIC), held July 28-August 1, in Philadelphia, Pennsylvania, Longeveron presented positive phase 2a clinical trial data (NCT05233774) and biomarker results assessing its investigational cell therapy Lomecel-B. The CLEAR MIND trial featured 48 patients who were 60-85 years old and had a diagnosis of mild Alzheimer disease (AD) in accordance with National Institutes of Health-Alzheimer’s Association criteria, a Mini-Mental State Examination (MMSE) score of 18-24, and a brain MRI and PET scan consistent with AD.

All told, the trial met its primary safety and secondary efficacy end points, with no incidence of hypersensitivity, infusion-related reactions, or cases of amyloid-related imaging abnormalities. In addition, Lomecel-B-treated patients (n = 36) showed an overall slowing of disease worsening compared with placebo. Administration of the cell product also was associated with slowing cognitive and functional decline as demonstrated by statistically significant results on the Montreal Cognitive Assessment and statistically trending improvements compared with placebo in Clinical Dementia Rating-Sum of Boxes and MMSE.

Additional data from the trial showed that Lomecel-B attenuated the loss in brain volume in areas associated with AD, including hippocampus, ventriculus, and thalamus. Along with positive changes in brain volume, there was a 20-30% reduction in left and right ventricular enlargement, respectively. Using diffusion tensor imaging MRI, results also revealed that Lomecel-B has potential to reduce neuroinflammation in this patient population.

Joshua Hare, MD, co-founder and chief science officer at Longeveron, sat down with NeurologyLive^® at the meeting to discuss the promise behind Lomecel-B and the emergence of cell and gene therapies for AD. He spoke on the mechanism of action of this agent, its encouraging safety profile, and its ability to penetrate central nervous system. Furthermore, he provided context on the cells used in this therapy and how they are able to affect AD disease milieus in complex ways.

Click here for more coverage of AAIC 2024.

REFERENCE
1. Longeveron® Presents Study Results from CLEAR MIND Phase 2a Clinical Trial of Lomecel-B™ in Mild Alzheimer’s Disease at the Alzheimer’s Association International Conference® (AAIC). News release. Longeveron. July 28, 2024. Accessed July 29, 2024. https://finance.yahoo.com/news/longeveron-presents-study-results-clear-205100606.html