Longeveron's Alzheimer's Candidate Meets Safety Goal In Mid-Stage Study

Longeveron Inc LGVN announced topline results from the Phase 2a trial of its investigational product Lomecel-B for 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 primary endpoint of safety was met based on statistical and medical assessment. One Serious Adverse Event (SAE) was reported on each Lomecel-B treatment group and none on placebo. 

The Data and Safety Monitoring Board (DSMB) reviewed and assessed each SAE 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).

Statistically significant improvement at Week 39 in Composite Alzheimer's Disease Score (CADS) was observed for the Lomecel-B 25 x 106 cells (25M) x 1 dose (p=0.091) versus placebo and the pooled Lomecel-B Groups (25M x 1 dose, 25M x 4 doses, 100 x 106 cells (100M) x 4 doses) (p=0.099).

Lomecel-B (25M x 1 dose) demonstrated statistically significant slowing of disease progression in left hippocampal volume (p=0.015) relative to placebo.

Other doses demonstrated numerical slowing/prevention of disease worsening relative to placebo.

Additional biomarker data is expected to be announced in the coming weeks.

Price Action: LGVN shares are down 4.41% at $2.40 on the last check Thursday.