Longeveron Announces Successful Completion of Phase 2b Clinical Study of Lomecel-B Infusion to Treat Aging Frailty

Rhea-AI Summary

Longeveron Inc. (NASDAQ: LGVN) has completed its Phase 2b clinical study of Lomecel-B for Aging Frailty, supported by a National Institute on Aging SBIR Grant. The study involved 149 subjects randomized to receive either Lomecel-B or a placebo, focusing on exercise tolerance and various health metrics. Top-line data is anticipated in Q3 2021. Aging Frailty affects approximately 8.1 million Americans over 65, leading to severe health complications. Lomecel-B aims to address inflammation related to this condition, and Longeveron is engaged in multiple clinical trials across various regions.

Positive

• Completion of Phase 2b clinical study of Lomecel-B for Aging Frailty.
• Study supported by NIH's National Institute on Aging, ensuring credibility.
• Next steps include anticipation of top-line data in Q3 2021.
• Potential market impact as there are no FDA-approved therapies for Aging Frailty.

Negative

• No immediate results or data published from the completed study.
• Relying on future data can lead to uncertainty in treatment viability.

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 3^rd 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 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.”

About Aging Frailty

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 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.

Lomecel-B for the Potential Treatment of Aging Frailty

Aging Frailty (and aging in general) is characterized 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’s Aging Frailty clinical research program is one of the most extensive in the world currently, with two ongoing Phase 2 clinical studies in the United States, a Treatment Registry Trial in Nassau, Bahamas, and a pending Phase 2 clinical trial set to initiate in Japan this year.

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 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; 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:
Crescendo Communications, LLC
Tel: 212-671-1020
Email: lgvn@crescendo-ir.com

FAQ

What are the objectives of the Lomecel-B trial?

The trial aims to evaluate Lomecel-B’s effects on physical function, mobility, strength, balance, endurance, and inflammatory biomarkers.

When will the top-line data for the Lomecel-B trial be announced?

Top-line data is expected to be announced in Q3 2021.

What is Aging Frailty and how does it affect patients?

Aging Frailty is a serious condition affecting about 15% of Americans over 65, leading to significant health risks and poor outcomes.

How many subjects were involved in the Lomecel-B study?

A total of 149 subjects were treated in the Phase 2b clinical study.

What is the significance of the Lomecel-B treatment for Aging Frailty?

Lomecel-B has the potential to address inflammation and improve health outcomes for Aging Frailty patients, a condition currently lacking FDA-approved treatments.