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Longeveron Announces Completion of Enrollment in Phase 2a Trial of Lomecel-B™ for the Treatment of Alzheimer’s Disease
MIAMI, Nov. 10, 2022 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) ("Longeveron" or "Company"), a clinical stage biotechnology company developing
About this update from Longeveron Inc.
[{"type":"text","content":"MIAMI, Nov. 10, 2022 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) (\"Longeveron\" or \"Company\"), a clinical stage biotechnology company developing regenerative medicines for unmet medical needs, today announced the completion of enrollment in its Phase 2a trial of Lomecel-BTM in patients with mild Alzheimer’s Disease (AD). “We are pleased to have completed enrollment in our Phase 2a study of Lomecel-BTM for Alzheimer’s Disease. We look forward to building on our Phase 1b study, which met its primary endpoint of safety and was published in a leading journal, Alzheimer’s and Dementia, the Journal of the Alzheimer’s Association this year. We are excited to advance our program designed to assess the therapeutic potential of Lomecel-BTM in patients with AD,” said Chris Min, M.D., Ph.D., Interim Chief Executive Officer and Chief Medical Officer of Longeveron. The Phase 2a trial follows the previously announced positive results of Longeveron’s Phase 1b clinical trial of Lomecel-BTM for AD. In that trial, the primary endpoint of safety was met. That trial was a randomized, placebo-control design and included endpoints in several domains, including measures of cognitive function and quality of life, brain volumetry using magnetic resonance imaging, and circulating biomarkers. The Phase 2a trial, called the CLEAR MIND trial, is a 48 patient, 4-arm, parallel design, randomized (1:1:1:1) clinical trial of Lomecel-BTM to evaluate the safety of single and multiple infusions of two different dose levels compared to placebo in patients with mild AD. The primary endpoint is safety as measured by the occurrence of serious adverse events (SAEs) within the first 30 days after administration of Lomecel-BTM. Secondary and exploratory endpoints include brain volumetry by magnetic resonance imaging (MRI), biomarkers relevant to inflammation and endothelial/vascular systems, and measures of cognitive function. About Longeveron Inc. Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Company’s lead investigational product is Lomecel-B™, an allogeneic medicinal signaling cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Lomecel-B™ has a multi-modal mechanism of action that is pro-vascular, pro-regenerative, and anti-inflammatory, promoting...