Business
Longeveron Inc. Provides Corporate Update and Reports Third Quarter 2022 Financial Results
-- Achieved key clinical and regulatory milestones across clinical pipeline, including the completion of enrollment in Longeveron’s Phase 2a trial for
About this update from Longeveron Inc.
[{"type":"text","content":"-- Achieved key clinical and regulatory milestones across clinical pipeline, including the completion of enrollment in Longeveron’s Phase 2a trial for Alzheimer’s Disease -- -- Conference call scheduled for 8:30 a.m. ET today -- MIAMI, Nov. 14, 2022 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) (\"Longeveron\" or \"Company\"), a clinical stage biotechnology company developing regenerative medicines for unmet medical needs, today provided a business update and reported its financial results for the third quarter ended September 30, 2022. “This quarter, we continued to make robust progress across our 3 clinical programs,” said Chris Min, M.D., Ph.D., Interim Chief Executive Officer, and Chief Medical Officer. “The FDA granted Fast Track Designation to Lomecel-BTM for infants with Hypoplastic Left Heart Syndrome (HLHS), a key step forward in our mission to transform the current standard-of-care in this disease area where there is a large unmet need. Additionally, we completed enrollment in our Phase 2a trial of Lomecel-BTM for patients with mild Alzheimer’s Disease and have all approvals in place to initiate enrollment in our Phase 2 trial for Aging Frailty in Japan. We were pleased to successfully execute on these key milestones and look forward to continuing to advance Lomecel-BTM.” Third Quarter Business Updates: Lomecel-BTM for Alzheimer’s Disease: Longeveron completed enrollment in a Phase 2a trial of Lomecel-BTM in patients with mild Alzheimer’s Disease (AD). Each patient is followed in the study for a duration of 12 months, and the Company expects to share topline results in 2024. The Phase 2a trial is designed as 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 Alzheimer’s Disease (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. Lomecel-BTM may have the potential to impact Alzheimer’s Disease by modulating neuroinflammation and vascular dysfunct...