Joshua M. Hare, MD, on Promising Data on Lomecel-B for Alzheimer Disease

“The hippocampus is a region that's heavily implicated in Alzheimer disease outcomes. It undergoes atrophy as part of the disease, and we slowed that atrophy rather substantially. This was a very exciting finding, and furthermore, we could show that the slowing of the atrophy correlated with clinical improvements in the cognitive scores. So, in summary, we definitely exceeded our expectations with the outcomes of the small study, and our conclusion is that we will go on and do a much larger, more clinically powered study now as our next step.”

Lomecel-B was well-tolerated in patients with mild Alzheimer disease (AD) receiving up to 4 infusions of the cell therapy and demonstrated some improvements in cognitive function and other disease measures. The updated data, from the phase 2a CLEAR MIND trial (NCT05233774), were presented at the 2024 Alzheimer’s Association International Conference (AAIC), held July 28-August 2nd in Philadelphia, Pennsylvania, by Brian G. Rash, PhD, vice president, research and discovery, Longeveron.

The therapy was well-tolerated, with no serious adverse events (AEs) related to Lomecel-B and no evidence of amyloid-related imaging abnormalities (ARIA).1Investigators observed improvements compared to placebo at 39 weeks on Composite Alzheimer’s Disease Score (CADS), Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), and AD Cooperative Scale-Activities of Daily Living (ADCS-ADL).

CGTLive spoke with Joshua M. Hare, MD, FACC, FAHA, cofounder, chief science officer, and chairman, Longeveron, and professor of medicine, Miller School of Medicine, University of Miami, to learn more about the new data from CLEAR MIND and the implications of the promising findings. He emphasized that Lomecel-B was found to be safe and substantially slowed atrophy of the hippocampus. He also shared that Longeveron would be meeting with the FDA soon to help inform the design of its next trial.

REFERENCE

Rash BG, Ramdas KN, Agafanova N, et al. The CLEAR MIND Study: Results from a Phase 2a Proof-of-Concept Double-Blind, Randomized, Placebo-Controlled Trial of Lomecel-BTM in Mild Alzheimer’s Disease Dementia. Presented at: 2024 AAIC, July 28-August 2; Philadelphia, Pennsylvania.