Longeveron Inc. LGVN announced Friday a clinical trial collaboration to study its lead investigational asset, Lomecel-B.
What Happened: Florida-based Longeverson said it has entered into a sponsored clinical research agreement with Japan's National Center for Geriatrics and Gerontology and the Juntendo University Hospital to study Lomcecel-B in older, frail Japanese subjects.
The Japanese Phase 2 study, approved by Japan's Pharmaceuticals and Medical Devices Agency, has a target enrollment of 45 subjects in three cohorts, randomized to receive a single intravenous infusion of Lomecel-B 50 million cells, Lomecel-B 100 million cells, or a placebo.
The primary objective is to evaluate the safety and explore the effect of Lomecel-B on physical function, activities of daily living, inflammation-related biomarkers such as cytokines in the blood and other endpoints.
"We believe our work could be especially impactful in Japan, which has one of the oldest and fastest aging populations in the world, and where early identification and intervention of frailty is a priority," said Geoff Green, CEO of Longeveron.
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Why It's Important: For Longeveron, the Japanese study could turn impactful, as the country is considered a "super-aged" society with approximately 29.1% of the population aged 65 or older in 2021, representing some 36.4 million individuals.
The overall prevalence of frailty amongst this demographic is estimated to be 7.9%.
Lomecel-B has been evaluated in Phase 1 and 2 aging frailty clinical studies in the U.S. The company had previously reported data from the U.S. Phase 2b study in aging frailty, showing subjects receiving a single infusion of Lomecel-B showed a statistically significant improvement in walking distance at day 270 post-infusion compared to placebo.
Longeveron's shares have been seeing strong momentum since Nov. 18, when the company reported the Food and Drug Administration granted a rare pediatric disease designation for Lomecel-B to treat hypoplastic left heart syndrome, a life-threatening heart condition in infants. A Phase 2 clinical trial is currently underway in babies with HLHS.
LGVN Price Action: Longeveron shares were up 0.038% at $26.26 Tuesday at market close.
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