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Longeveron Announces Successful Completion of Phase 2b Clinical Study of Lomecel-B Infusion to Treat Aging Frailty
Trial funded in part by a National Institute on Aging Small Business Innovation Research (SBIR) Grant Trial objectives include evaluation of Lomecel-B’s
About this update from Longeveron Inc.
[{"type":"text","content":"Trial funded in part by a National Institute on Aging Small Business Innovation Research (SBIR) Grant Trial objectives include evaluation of Lomecel-B’s effect on physical function, mobility, strength, balance, endurance, fear and risk of falling, inflammatory biomarkers and clinical outcomes Top-line data expected in Q3 2021 MIAMI, March 03, 2021 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) (\"Longeveron\" or \"Company\"), a clinical stage biotechnology company developing cellular therapies for chronic aging-related and life-threatening conditions, announced today the completion of the Company’s Phase 2b clinical study of Lomecel-B infusion for Aging Frailty subjects. Lomecel-B is an allogeneic, bone marrow-derived medicinal signaling cell (MSC) product manufactured under cGMP in Longeveron’s cell processing facility in Miami. The multicenter study was conducted at 8 hospitals and clinics, primarily in South Florida, including the Miami VA Healthcare System, and was supported in part by a Small Business Administration Grant (SBIR) grant from the NIH’s National Institute on Aging (NIA). It is anticipated that the top-line trial results will be announced in the 3rd quarter of 2021. Trial subjects were randomized to receive a single peripheral intravenous infusion of Lomecel-B (25 million, 50 million, 100 million or 200 million cells), or placebo, followed by a 52 week observation period to evaluate safety and efficacy. A total of 149 subjects were treated, and the primary objective of the study is to assess the effect of Lomecel-B treatment on exercise tolerance and endurance via the six-minute walk test (6MWT). Additional endpoints include gait speed, grip strength, short physical performance battery (SPPB), Performance Oriented Mobility Assessment (POMA; measures subject’s risk of falling), the Falls Efficacy Scale (measures subject’s fear of falling), depression, sexual function, cognition, and various patient reported outcomes (PROs) and activities of daily living (ADLs), and blood-based biomarkers. “Completion of our Phase 2b clinical study of Lomecel-B Infusion to treat Aging Frailty marks a major milestone for the Company,” commented, Geoff Green, Chief Executive Officer of Longeveron. “We are grateful to the exceptional clinical trial sites, our partner the National Institute on Aging, and of course the subjects for...