Longeveron Inc (NASDAQ: LGVN) has initiated its Phase 2a clinical trial evaluating Lomecel-B for Alzheimer’s disease (AD). The first patient has consented to participate in the trial, and patient screening has begun.
What Happened: The Phase 2a study intends to build on encouraging preliminary Phase 1 data announced in April 2021.
Data showed that the average cognitive function score declined more slowly in the low-dose Lomecel-B group compared to the placebo group.
The lomecel-B infusion was well-tolerated in this trial, with no treatment-related serious adverse events observed throughout the 1-year follow-up.
Why it Matters: The Phase 2a trial is a double-blind, randomized, placebo-controlled design to investigate safety and tolerability.
Secondary endpoints 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.
The 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 will be conducted at a minimum of 6 centers.
Price Action: LGVN shares traded 1.72% lower at $11.40 premarket on the last check Wednesday.
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