Longeveron announces successful completion of phase 2b clinical study of Lomecel-B infusion to treat aging frailty.
Longeveron Inc, 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.
Longevity.Technology: Lomecel-B is an allogeneic, bone marrow-derived medicinal signalling cell (MSC) product manufactured under Current Good Manufacturing Practice in Longeveron’s cell processing facility in Miami. The multicentre study was conducted at eight hospitals and clinics, primarily in South Florida, including the Miami VA Healthcare System, and was supported in part by a 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, and this could be further good news for Longeveron, which filed for a $30m IPO in January.
Trial subjects were randomised 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 (which measures subject’s risk of falling), the Falls Efficacy Scale (measures subject’s fear of falling), depression, sexual function and cognition. Also assessed were various patient reported outcomes and activities of daily living, as well as blood-based biomarkers.
“We are committed to developing safe and effective cell therapies for chronic aging-related diseases and life-threatening conditions, and we look forward to sharing the trial data later this year…”
“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 their participation in this study. We are committed to developing safe and effective cell therapies for chronic aging-related diseases and life-threatening conditions, and we look forward to sharing the trial data later this year.”
Aging Frailty is a life-threatening geriatric condition affecting approximately 15% of Americans over the age of 65, or 8.1 million individuals. Aging Frailty patients are vulnerable to poor clinical outcomes compared with their age-matched peers despite sharing similar comorbidities and demographics, and therefore it is considered an extreme form of unsuccessful aging. Clinically, frailty manifests as a combination of symptoms that includes loss of muscle and decreased strength, slowed walking, low activity and energy levels, poor endurance, nutritional deficiencies, weight loss and fatigue.
Individuals with Aging Frailty have decreased reserves and a reduced ability to cope with minor illnesses or stressors that would normally have minimal impact, such as an infection or a fall. As a result the individual may be more likely to be hospitalised, need long term care or die. Inflammation can contribute to the physical decline in Aging Frailty through multiple mechanisms, including detrimental effects on muscles, bone tissue, the immune system, cardiovascular function, and cognition.
The necessity for identifying patients with Aging Frailty is well-acknowledged in the geriatric community, and the treatment of Aging Frailty and promotion of healthful aging are recognised priorities of the National Academy of Medicine and NIA/NIH. Despite the pressing need for interventions, there are no FDA-approved therapies that can slow down, reverse, or prevent Aging Frailty.
Aging Frailty (and aging in general) is characterised by diminished number and function of circulating MSCs. Therefore, treatments that can positively affect and/or replenish these endogenous stem cell functions could be of therapeutic value for Aging Frailty. Lomecel-B has the potential to reduce inflammation associated with Aging Frailty, and to promote an anti-inflammatory state by releasing anti-inflammatory molecules, which can promote physiological restoration to a more normal state.
Longeveron claims its Aging Frailty clinical research programme is one of the most extensive in the world currently; there are two ongoing Phase 2 clinical studies in the US, a Treatment Registry Trial in Nassau, Bahamas, and a pending Phase 2 clinical trial set to initiate in Japan this year.