Cell therapy Lomecel-B shows promising effects in Phase 2a trial

Early Alzheimer's patients saw improvements in cognitive tests vs. placebo

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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Experimental Dementia Treatment AL001 | Alzheimer's News Today | Alzamend Neuro | illustration of a bottle labeled clinical trial

The cell therapy candidate Lomecel-B significantly improved cognitive function and reduced brain volume loss relative to a placebo in a Phase 2a clinical trial of people with mild Alzheimer’s disease, according to new data announced by the treatment’s developer Longeveron.

“We believe these new data may provide evidence for Lomecel-B’s mechanism of action and add to the robust foundation we are building for its further investigation in Alzheimer’s disease as well as other indications,” Wa’el Hashad, CEO of Longeveron, said in a company press release.

Administered directly into the bloodstream, Lomecel-B contains cells derived from the bone marrows of healthy donors that, according to Longeveron, are able to promote tissue repair and reduce brain inflammation, which may be beneficial in Alzheimer’s.

The new data “demonstrated statistically significant improvements in the Montreal Cognitive Assessment (MOCA), relative to placebo,” the press release stated. Further, two imaging measures “showed improvement in brain architecture,” per the release.

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In a previous Phase 1 trial (NCT02600130), the cell therapy was generally well-tolerated by patients with mild Alzheimer’s, while slowing cognitive decline and improving life quality compared with a placebo. Lomecel-B also was linked to increased levels of anti-inflammatory markers.

The Phase 2a trial, called CLEAR MIND (NCT05233774), evaluated the safety and efficacy of Lomecel-B in 49 adults, ages 60-85, with mild Alzheimer’s, who were recruited at 10 U.S. sites.

The participants were randomly divided into four dosing groups; all involved four monthly infusions and several months of follow-up.

In the first group, all four infusions were placebos. The second group received 25 million Lomecel-B cells on the first infusion, and a placebo for the remaining three infusions. A third group received 25 million cells at all four infusions, and the fourth group got 100 million cells at each of the four infusions.

Top-line results, announced in October, showed the trial met its primary goal of safety, with the therapy being generally safe and well-tolerated.

One serious safety issue was reported in each of the Lomecel-B groups, while no serious events were reported in the placebo group. Longeveron did not provide specifics about these serious events, but noted that none were considered a treatment-related safety issue.

The trial’s secondary goal also was met. Specifically, pooled data from the three Lomecel-B-treated groups showed significantly better scores on the Composite Alzheimer’s Disease Score (CADS) at about nine months than seen among those in the placebo group.

The group that received one dose of 25 million cells also showed statistically significant improvements in CADS compared with those given only the placebo.

CADS comprised validated measures of cognitive function, dementia, and ability to perform daily life activities, as well as hippocampal volume. The hippocampus is the brain region critical for memory that is initially and strongly affected in Alzheimer’s.

The newly announced 9-month data concerned some of the trial’s exploratory goals, including other cognitive tests, quality of life, brain volume, and neuroinflammation.

These new data support our initial results for CLEAR MIND that we announced in October and provide further validation of both the safety and therapeutic potential of Lomecel-B in the treatment of mild Alzheimer’s disease.

These results showed that the pooled Lomecel-B groups, and the group given a single 25 million cell dose, all performed significantly better than those given a placebo on the MOCA test.

Dose-dependent improvements on the Mini-Mental State Examination also were reported, with the highest dose of Lomecel-B (four infusions of 100 million cells) leading to significant cognitive gains relative to the study’s start.

Patients given the highest dose also experienced significant life quality improvements, as measured by the Alzheimer’s Disease Related Quality of Life scale. This high dose also was associated with 49% less brain volume loss and 20%-30% less enlargement of the brain’s fluid-filled cavities relative to a placebo.

Also, the group of patients given the lowest Lomecel-B dose and the pooled treatment group showed significantly less hippocampal volume loss than the placebo group.

All Lomecel-B doses were linked to lower levels of brain inflammation compared with a placebo, according to Longeveron.

“These new data support our initial results for CLEAR MIND that we announced in October and provide further validation of both the safety and therapeutic potential of Lomecel-B in the treatment of mild Alzheimer’s disease,” Hashad said.