Longeveron® Announces Positive Type B Meeting with U.S. FDA Regarding Pathway to BLA for Laromestrocel (Lomecel-BTM) in Alzheimer's Disease

Core Insights - Longeveron Inc. announced a positive outcome from a Type B meeting with the FDA regarding laromestrocel (Lomecel-B™) as a potential treatment for Alzheimer's disease [1][2] - The FDA and the company aligned on the study design for a pivotal Phase 2/3 clinical trial, which includes patient population, placebo control, dosing, trial duration, and endpoints [2][8] - The FDA granted laromestrocel both RMAT and Fast Track designations, facilitating closer interaction during development [6][8] Company Overview - Longeveron is a clinical stage biotechnology company focused on developing regenerative medicines for unmet medical needs, with laromestrocel as its lead investigational product [12] - The company is pursuing multiple indications, including Alzheimer's disease, hypoplastic left heart syndrome, and aging-related frailty [12] Clinical Trial Details - The planned pivotal Phase 2/3 clinical trial is expected to begin in the second half of 2026, contingent on securing non-dilutive funding or partnerships [5][8] - Previous clinical trials, including a Phase 1 study and a Phase 2a trial (CLEAR-MIND), demonstrated a favorable safety profile and potential clinical efficacy in patients with mild Alzheimer's disease [3][4] Mechanism of Action - Laromestrocel is derived from mesenchymal stem cells (MSCs) and is believed to have multiple mechanisms of action that may address inflammatory responses associated with Alzheimer's disease [7][11] - The therapy aims to tackle the underlying pathology of Alzheimer's without the limitations of existing treatments [5] Alzheimer's Disease Context - Alzheimer's disease is a leading cause of dementia, significantly impacting patients, families, and society, with substantial economic costs [9] - Neuroinflammation is a key feature of Alzheimer's, contributing to the disease's progression and associated cognitive decline [10]