Cellular Therapy Receives FDA Fast Track Designation for Potential Treatment of Alzheimer Disease

Lomecel-B (Longeveron, Miami, Fl), an allogenic cellular therapy, has been granted Fast Track Designation by the Food and Drug Administration (FDA) for investigation for potential applications in Alzheimer disease (AD), aging-related frailty, and hypoplastic left heart syndrome. The Fast Track Designation was supported by positive topline data from the phase 2a CLEAR MIND clinical trial (NCT05233774), which will be presented at the 2024 Alzheimer’s Association International Conference.

CLEAR MIND is a randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of Lomecel-B as a treatment for AD. The study enrolled 50 people aged 60 to 85 years with a clinical diagnosis of mild AD. Participants received either placebo or an infusion of Lomecel-B at 3 dose levels, with primary endpoints evaluating safety and secondary endpoints evaluating efficacy in terms of changes in cognitive function and AD biomarkers. According to a statement from Longeveron, treatment with Lomecel-B was associated with slowed AD disease worsening in results of the study.

Wa’el Hashad, CEO of Longeveron, said, “We believe that Lomecel-B, which demonstrated an overall slowing/prevention of disease worsening compared to placebo in the CLEAR MIND Phase 2a clinical trial, has the potential to become an important treatment option for physicians and patients, and we look forward to sharing the latest data with the Alzheimer’s Disease research and patient communities at AAIC 2024.”