MIAMI, Jan. 12, 2022 — Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or the “Company”), a clinical stage biotechnology company developing cellular therapies for chronic aging-related and certain life-threatening conditions, announced today publication of the design and rationale from its recently completed Phase 2b aging frailty clinical trial with Lomecel-B in the Journal of Frailty and Aging. This peer-reviewed article describes the design of the trial which investigated Lomecel-B, a living cell therapy product, as a regenerative medicine strategy for the treatment of frailty in older adults.
As a life-threatening geriatric condition, aging frailty affects up to 15% of Americans over the age of 65, or 8.1 million individuals, and manifests as a loss of muscle and decreased strength, slowed walking, low activity and energy levels, poor endurance, nutritional deficiencies, weight loss and fatigue.
“There is increasing recognition of the unmet medical need in treating and preventing frailty in older adults, and we feel the acceptance of our trial design and rationale for publication in this prestigious, peer-reviewed journal reflects the urgency to develop potential new therapies,” said Geoff Green, CEO of Longeveron.
The publication by Longeveron Senior Scientist Dr. Anthony Oliva and colleagues is titled “The Design and Rationale of a Phase 2b, Randomized, Double-Blinded, and Placebo-Controlled Trial to Evaluate the Safety and Efficacy of Lomecel-B in Older Adults with Frailty,” and is accessible here (https://link.springer.com/article/10.14283/jfa.2022.2) This trial was designed and conducted in partnership with the National Institute on Aging. The results of the trial were previously announced by the Company on August 13th, 2021.
About Aging Frailty
Aging Frailty is a life-threatening geriatric condition, which studies have estimated affect approximately 15% of Americans over the age of 65, or 8.1 million individuals. Aging Frailty patients are vulnerable to poor clinical outcomes compared to 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. Aging Frailty is also associated with chronic low-level sterile inflammation. 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 hospitalized, 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 recognized 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.
About Longeveron Inc.
Longeveron is a clinical stage biotechnology company developing cellular therapies for specific aging-related and life-threatening conditions. The Company’s lead investigational product is the LOMECEL-B™ cell-based therapy product (“Lomecel-B”), which is derived from culture-expanded medicinal signaling cells (MSCs) that are sourced from bone marrow of young, healthy adult donors. Longeveron believes that by using the same cells that promote tissue repair, organ maintenance, and immune system function, it can develop safe and effective therapies for some of the most difficult disorders associated with the aging process and other medical disorders. Longeveron is currently sponsoring Phase 1 and 2 clinical trials in the following indications: Aging Frailty, Alzheimer’s disease, the Metabolic Syndrome, Acute Respiratory Distress Syndrome (ARDS), and hypoplastic left heart syndrome (HLHS). The Company’s mission is to advance Lomecel-B and other cell-based product candidates into pivotal Phase 3 trials, with the goal of achieving regulatory approvals, subsequent commercialization, and broad use by the healthcare community. Additional information about the Company is available at www.longeveron.com.