EXCLUSIVE: Longeveron Spikes As Lead Drug Produces Dose-Dependent Response In Aging Frailty Study; Primary Endpoint Not Met

Florida-based biopharma Longeveron Inc. LGVN, which is engaged in the development of cell therapies for chronic age-related and life-threatening conditions, announced Friday results for a mid-stage study of its lead candidate.

What Happened: Longeveron said data from the Phase 2b study of its lead product candidate Lomecel-B in aging frailty subjects showed that the four Lomecel-B cohorts did not show a statistically significant difference when compared to the placebo cohort for the primary efficacy endpoint of change in six-minute walk test distance at 180 days post-infusion.

All the cohorts, however, showed a mean increase from baseline.

The mid-stage study evaluated the safety and efficacy of a single peripheral intravenous infusion of four different doses of Lomecel-B cell therapy.

The secondary analysis, which was to determine whether a dose-response relationship exists using the multiple comparisons and modeling approach, showed a clear, statistically significant dose-response curve at day 180. Pairwise comparison to placebo at Day 180 did not achieve statistical significance, the company said.

Significant differences from placebo were observed at day 270, which was a pre-specified exploratory endpoint.

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"We are very pleased to report a statistically significant dose response curve with our cell therapy product," said Geoff Green, CEO of Longeveron.

One of the main objectives of this trial was to determine whether a dose response relationship could be demonstrated in the primary efficacy endpoint, he added.

The safety profile of Lomecel-B continued to look very good, with no Lomecel-B related serious adverse events reported in this study.

Why It's Important: One-third of the U.S. Veterans above 65 years have frailty and therefore, these results are clinically significant and relevant, said Dr. Jorge G. Ruiz, a geriatrician at the Miami Veterans Affairs Healthcare System, Geriatric Research, Education and Clinical Center.

Currently, there are no FDA-approved therapies that can slow down, reverse, or prevent aging frailty.

Longeveron said it plans to review the trial data during an upcoming steering committee comprised of independent frailty experts, and plan its next steps for the program. The company also plans to present clinical data from the trial at the 2021 International Conference on Frailty & Sarcopenia Research on Sept. 29, at 11:30 am.

LGVN Price Action: Shares are up 34% to $7.25 in Friday's premarket session.