Joshua M. Hare, MD, on Working to Address Unmet Needs in Alzheimer Disease With Lomecel-B Cell Therapy

“There is directional, actual improvement in some of the cognitive scores... not just a slowing of decline, but actually an increase towards the positive direction in the MMSE and the MoCA scores. So, these are very early days, and we don't want to [read too into] it, but we're very excited about that. Of course, we'll be looking at that very carefully in the next larger study that we do, which will be powered around the efficacy endpoint... If we have an agent here that can actually improve cognitive function in the mild AD patients, that would be a very exciting outcome, one very clinically meaningful for affected patients and their families.”

Patients with mild Alzheimer disease (AD) enrolled in the phase 2a CLEAR MIND trial (NCT05233774) tolerated up to 4 infusions of Lomecel-B cell therapy well and experienced some improvements in cognitive function and other disease measures. The updated data 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.

Participants experienced no serious adverse events (AEs) related to Lomecel-B and no evidence of amyloid-related imaging abnormalities (ARIA). They also experienced 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 unmet need in people with AD for disease-modifying therapies and how Lomecel-B has the potential to produce some benefit in these patients. He also emphasized the positive safety profile seen in the data and the lack of ARIA.

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.