Longeveron Inc. announced the initiation of its Phase 2a clinical trial evaluating Lomecel-B as a treatment for Alzheimer's disease (AD). The first patient has consented to participate in the trial and patient screening has begun. This Phase 2a study is intended to build on encouraging preliminary Phase 1 data that were announced in 2021.

Additionally, the Phase 2a trial is designed to measure brain anatomy using MRI, and include detailed assessments of the inflammatory and vascular systems thought to contribute to the worsening of AD. The study, which will be conducted at a minimum of 6 centers, is led by Mark L. Brody, MD, of Brain Matters Research, Delray Beach, Florida. Dementia resulting from AD is associated with vascular function decline and involves a pro-inflammatory state.

In Longeveron's prior Phase 1 trial, Lomecel-B treatment met the primary safety endpoint, with no safety concerns – including no evidence of Alzheimer's-related imaging abnormality, known as ARIA. In addition, the levels of certain pro-vascular and anti-inflammatory biomarkers increased in the Lomecel-B treated subjects compared to placebo. The Phase 2a trial is a double-blind, randomized, placebo-controlled design investigating safety and tolerability, as well as secondary endpoints that include cognitive function and biomarkers, following single or multiple infusions of Lomecel-B compared to placebo, in individuals with mild AD.

The study consists of 4 treatment arms of 12 patients each, for a total target enrollment of 48 patients.