Longeveron Announces Publication of Lomecel-B Phase 2b Trial Design in Journal of Frailty and Aging

Rhea-AI Summary

Longeveron Inc. (NASDAQ: LGVN) announced the publication of its Phase 2b clinical trial design for Lomecel-B, aimed at addressing aging frailty in older adults, in the Journal of Frailty and Aging. This condition affects up to 15% of Americans over 65, marking a significant medical need. The publication reflects the urgency in developing therapies for frailty, a condition linked to poor outcomes in older adults. The trial focused on the safety and efficacy of Lomecel-B, developed from medicinal signaling cells, with aims to advance into pivotal Phase 3 trials.

Positive

• Publication of the trial design in a peer-reviewed journal highlights the significance and acceptance of the research.
• The trial addresses a critical need for therapies targeting aging frailty, which affects 15% of seniors.

Negative

• None.

MIAMI, Jan. 12, 2022 (GLOBE NEWSWIRE) -- 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 13^th, 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.

Forward-Looking and Other Statements

Certain statements in this press release that are not historical facts are forward-looking statements that reflect management's current expectations, assumptions, and estimates of future performance and economic conditions, and involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as "believe," "expects," "may," "looks to," "will," "should," "plan," "intend," "on condition," "target," "see," "potential," "estimates," "preliminary," or "anticipates" or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects. Moreover, forward-looking statements in this release include, but are not limited to, statements about the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results, including achievement of primary endpoints; the timing and focus of our ongoing and future preclinical studies and clinical trials; the size of the market opportunity for our product candidates, the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; our ability to obtain and maintain regulatory approval of our product candidates, our plans and ability to obtain or protect intellectual property rights, including extensions of existing patent terms where available and our ability to avoid infringing the intellectual property rights of others. Further information relating to factors that may impact the Company's results and forward-looking statements are disclosed in the Company's filings with the SEC. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

Contact:
Brendan Payne
Stern Investor Relations
Tel: (212) 362-1200
Email: Brendan.payne@sternir.com

Source: Longeveron Inc
Source: LGVN

Source: Longeveron

FAQ

What is Longeveron Inc.'s recent announcement regarding LGVN?

Longeveron announced the publication of the design and rationale of its Phase 2b clinical trial for Lomecel-B, focusing on treating aging frailty.

What condition does the Lomecel-B trial target?

The Lomecel-B trial targets aging frailty, which affects around 8.1 million older Americans.

What are the implications of the Phase 2b trial results for LGVN's future?

Successful results could lead to Longeveron advancing to Phase 3 trials and potential FDA approval for Lomecel-B.

When were the previous results of the Lomecel-B trial announced?

The results were previously announced on August 13, 2021.

What is the significance of aging frailty in geriatric health?

Aging frailty is a critical geriatric condition with no FDA-approved therapies to address its symptoms and risks.