Lomecel-B CLEARMIND Phase 2a Trial Results to Be Presented at AAIC

Study results from the phase 2a clinical trial CLEARMIND (NCT05233774) have been accepted for a Featured Research Oral Presentation at the 2024 Alzheimer’s Association International Conference (AAIC), which will be held July 28 to August 1 in Philadelphia, Pennsylvania. The trial evaluated Lomecel-B (Longeveron) in patients with mild Alzheimer Disease and the oral presentation is titled “Results from a Phase 2a Proof-of-Concept Double-Blind, Randomized, Placebo-Controlled Trial of Lomecel-BTM in Mild Alzheimer’s Disease Dementia” and the poster presentation is titled “Magnetic Resonance Imaging [MRI] results in the CLEARMIND phase 2a clinical trial of Lomecel-BTM”.¹

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Lomecel-B is an investigational cellular therapy that is currently being evaluated in clinical trials for the treatment in Alzheimer disease, as well as other aging-related chronic diseases and life-threatening conditions. The therapy is made from living cells, called medicinal signaling cells (MSCs), which are isolated from fresh bone marrow tissue donated by adults aged 18 to 45 years. Its therapeutic effects are through the secretion of bioactive molecules and direct cell-to-cell contact at the site of inflamed or damaged tissue. Lomecel-B has been granted investigational new drug applications by the FDA and is referred to as an allogeneic product because it is donor-derived.^1,2

CLEARMIND is a randomized, double-blind, placebo-controlled phase 2a trial evaluating the efficacy and safety profile of Lomecel-B in patients aged 60 to 85 years of age with mild Alzheimer disease. This phase 2a trial expands on preliminary phase 1 results, and is intended to evaluated the safety profile of multiple Lomecel-B infusions as well as determine provisional efficacy of single dosing compared with multiple dosing.³

Patients were randomly assigned to receive either placebo or Lomecel-B. Patients receiving placebo (group 1) were administered 4 infusions on day 0 and the start of weeks 4, 8, and 12. Additionally, patients receiving the investigational therapy were divided into 1 of 3 groups: a single infusion of Lomecel-B (25 x 10⁶ cells [25M]) on day 0 then placebo infusions at the start of weeks 4, 8, and 12 (group 2); 4 infusions of Lomecel-B (25M) on day 0 and the start of weeks 4, 8, and 12 (group 3); and 4 infusions of Lomecel-B (100 x 10⁶ cells [100M]) on day 0 and the start of weeks 4, 8, and 12.³

The primary end points of CLEARMIND are related to safety and assessed at the 41-week mark. These included the incidence of all adverse events (AEs)—all grades and severity—and imaging abnormalities related to Alzheimer diseaseor clinically asymptomatic microhemorrhages as shown by MRI. In addition, secondary end points are related to efficacy and include the changes from baseline to the 41-week mark in the Lomecel-B groups, which were measured by the 13-item cognitive subscale Alzheimer's Disease Assessment Scale and Mini-Mental State Examination.³

Previously, Longeveron announced topline results from the phase 2a clinical trial on October 5, 2023, and additional data and imaging biomarker results on December 20, 2023. Currently, the company is also developing and pursuing 3 pipeline indications for hypoplastic left heart syndrome, Alzheimer disease, and age-related fraility.¹

“We are extremely excited to share the full study results of our CLEARMIND trial at the AAIC meeting this year, and have the opportunity to present at the leading forum for Alzheimer’s disease clinical investigation,” said Wa’el Hashad, CEO of Longeveron, in a news release.¹

References

1. GlobeNewswire. Longeveron’s CLEAR MIND Randomized Phase 2a Clinical Trial Evaluating Lomecel-B™ in Mild Alzheimer’s Disease Accepted for Featured Research Session Oral Presentation at the 2024 Alzheimer’s Association International Conference (AAIC). News release. April 15, 2024. Accessed July 17, 2024. https://www.globenewswire.com/en/news-release/2024/04/15/2862761/0/en/Longeveron-s-CLEAR-MIND-Randomized-Phase-2a-Clinical-Trial-Evaluating-Lomecel-B-in-Mild-Alzheimer-s-Disease-Accepted-for-Featured-Research-Session-Oral-Presentation-at-the-2024-Alz.html

2. Lomecel-B. Longeveron. May 14, 2024. Accessed July 17, 2024. https://longeveron.com/lomecel-b/

3. Lomecel-B Effects on Alzheimer's Disease (CLEARMIND).ClinicalTrials.gov identifier: NCT05233774. Updated February 20, 2024. Accessed July 17, 2024. https://clinicaltrials.gov/study/NCT05233774