Why Is Alzheimer's-Focused Longeveron Stock Trading Higher On Monday?

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 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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