EXCLUSIVE: Longeveron Announces Biomarker Analysis Data From Mid-Stage Study Of Anti-Aging Cell Therapy Candidate

Longeveron Inc. LGVN announced Wednesday positive biomarker analysis data from the mid-stage study of its lead cell therapy candidate in aging frailty subjects.

What Happened: Florida-based Longeveron said ongoing biomarker analysis from the Phase 2b study of Lomecel-B investigational cell therapy in aging frailty subjects showed that administration of the investigational therapy was associated with a significant reduction in serum levels of soluble TIE-2 in a dose-dependent fashion at Day 270 compared to placebo.

Reductions in sTIE-2 correlate with anti-inflammatory and pro-vascular effects, while elevated levels of sTIE2 have been observed in patients with peripheral arterial disease and are an indication of poor vascular health, the company said.

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Since poor vascular health and endothelial dysfunction are associated with the onset and development of frailty in older adults, the finding that Lomecel-B can reduce sTIE-2 suggests that improving vascular and endothelial function may be a potential mechanism of action of this product.

"This is the first time that a cell therapy has been associated with a reduction in sTIE-2 in the bloodstream," the company said.

What's Next: Longeveron plans to further explore the Tie-2 changes in additional subject populations with Aging Frailty.

The study's lead investigator Jorge Ruiz is scheduled Wednesday to present results from the trial at the 2021 11th Annual International Conference for Frailty & Sarcopenia.

Longeveron announced in mid-August data from the study that showed all cohorts showed mean increases in six-minute walk test distance from the baseline, at 180 days post-infusion, although statistically significant difference was not demonstrated.

In premarket trading, the stock was up 0.80% at $3.79.