Longeveron Inc. announced positive top-line results from its Phase 2a trial of its investigational product Lomecel-B for the treatment of mild Alzheimer?s disease. An estimated 6.7 million Americans are living with Alzheimer?s disease. Of the total U.S. population, about 1 in 9 people aged 65 and older has Alzheimer?s disease.

The percentage of people with Alzheimer?s disease increases with age. Despite progress for new anti-amyloid treatment, there remains a high unmet medical need. The primary endpoint of safety was met based on statistical and medical assessment.

There was one Serious Adverse Event (SAE) reported on each Lomecel-B? treatment group and none on placebo. Each SAE was reviewed and assessed by the Data and Safety Monitoring Board (DSMB) with no safety issues raised. The study safety data were consistent with an established safety profile with no incidence of hypersensitivity, no cases of Alzheimer Related Imagine Abnormalities (ARIA), no clinically asymptomatic microhemorrhages as revealed by Magnetic Resonance Imaging (MRI), and no notable changes in laboratory evaluations and electrocardiogram (EKG).

In terms of the specific components of the CADS score, evaluated at p<0.05, 2-tailed: Lomecel-B? (25M x 1 dose) demonstrated statistically significant slowing of disease progression in left hippocampal volume (p=0.015) relative to placebo, ADCS-ADL and left hippocampal volume at Week 39 were statistically significant for the pooled Lomecel-B? treatment groups (25M x 1 dose, 25M x 4 doses, 100M x 4 doses) relative to placebo (p=0.047) and (p=0.038), Other doses demonstrated numerical slowing and prevention of disease worsening relative to placebo in CADS, ADAS-cog13, CDR-SB, ADCS-ADL and left hippocampal volume at Week 39.