On Sunday, Longeveron Inc ( LGVN ) presented Phase 2a clinical trial data and biomarker results at the Alzheimer’s Association International Conference (AAIC).

The Phase 2a CLEAR MIND trial evaluated 48 patients (36 were treated with Lomecel-B, and 12 received placebo).

The clinical trial achieved its primary safety and secondary efficacy endpoints, and the study results presented at AAIC 2024 support Lomecel-B’s therapeutic potential.

Key findings include:

The established safety profile of Lomecel-B for single and multiple dosing regimens was demonstrated in study data that showed no incidence of hypersensitivity, infusion-related reactions, and no cases of amyloid-related imaging abnormalities (ARIA).

Patients treated with Lomecel-B showed an overall slowing of disease worsening compared to placebo.

Efficacy results were demonstrated via a change from baseline at week 39 of the trial at prespecified levels using the Composite Alzheimer’s Disease Score (CADS), a secondary outcome measure that combines information across cognitive, functional capacity, and brain MRI domains.

Administration of Lomecel-B was associated with slowing cognitive and functional decline.

There was a statistically significant improvement relative to placebo observed in the Alzheimer’s Disease Cooperative Study Activities of Daily Living (ADCS-ADL).

Lomecel-B minimized the loss in brain volume in areas associated with Alzheimer’s Disease, statistically significant for left hippocampal volume relative to placebo. Along with positive changes in brain volumes, there was a 20-30% reduction in left and right ventricular enlargement, respectively.

Diffusion tensor imaging MRI supports the concept that Lomecel-B can potentially reduce neuroinflammation compared to placebo.

In October last year, Longeveron ( LGVN ) announced topline results from the Phase 2a trial of its investigational product Lomecel-B for mild 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. 

Earlier this month, the company announced that the FDA granted Regenerative Medicine Advanced Therapy (RMAT) designation to Lomecel-B for mild Alzheimer’s Disease.

Price Action: LGVN stock is up 22.10% at $4.20 during the premarket session at last check Monday.

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