Longeveron Inc. Reports Positive Phase 2a Results for Laromestrocel (Lomecel-B™) in Mild Alzheimer’s Disease Treatment

Phase 2a trial results show laromestrocel (Lomecel-B™) improves cognitive function and brain volume in mild Alzheimer's disease patients.

Quiver AI Summary

Longeveron Inc. announced positive results from its Phase 2a CLEAR MIND clinical trial of laromestrocel (Lomecel-B™), a cellular therapy for mild Alzheimer's disease, published in Nature Medicine. The trial demonstrated laromestrocel's safety and efficacy, showing improvements in cognitive function, quality of life, and brain volume compared to a placebo. Key findings indicated that patients treated with laromestrocel experienced slowed cognitive decline and minimized loss of brain volume in key regions affected by Alzheimer's. The treatment also received both Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations from the FDA, indicating its potential for further development in addressing this unmet medical need.

Potential Positives

• Positive Phase 2a clinical trial results indicate laromestrocel (Lomecel-B™) improves cognitive function, quality of life, and minimizes brain volume loss in patients with mild Alzheimer’s disease.
• Publication in Nature Medicine validates the safety and efficacy of laromestrocel (Lomecel-B™) as a potential treatment for Alzheimer’s, enhancing the company’s credibility in the field.
• Longeveron has received both Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation from the FDA for laromestrocel (Lomecel-B™), facilitating expedited development and review processes.

Potential Negatives

• Company highlighted its financial challenges, indicating a need for additional capital that could dilute current investor holdings and impact future operations.
• The press release mentions numerous uncertainties and risks related to the efficacy and safety of their product candidates, which could hinder investor confidence and perceptions of stability.
• Despite positive results from the trial, the relatively small sample size of the study (48 patients) may raise concerns regarding the generalizability of the findings and its implications for broader regulatory approval.

FAQ

What are the key findings of the CLEAR MIND Phase 2a trial?

The trial showed laromestrocel (Lomecel-B™) improved cognitive function, quality of life, and minimized brain volume loss in mild Alzheimer's patients.

What is laromestrocel (Lomecel-B™)?

Laromestrocel (Lomecel-B™) is a mesenchymal stem cell therapy aimed at treating mild Alzheimer's disease, targeting underlying pathology, and neuroinflammation.

How does laromestrocel (Lomecel-B™) affect patients' quality of life?

Patients treated with laromestrocel (Lomecel-B™) reported improvements in quality of life measures observed by caregivers in the trial.

What FDA designations has laromestrocel (Lomecel-B™) received?

Laromestrocel (Lomecel-B™) has received the Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations for mild Alzheimer's disease.

Where can I find more information about the study?

The study results are published in Nature Medicine and additional details are available on Longeveron’s official website.

Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.

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Full Release

• 
  
  Phase 2a results demonstrated laromestrocel (Lomecel-B™) improved cognitive function, quality of life, and brain volume in the treatment of mild Alzheimer’s disease
  
  


• 
  
  This encouraging clinical trial data adds to the body of evidence supporting the safety of single and multiple doses of laromestrocel (Lomecel-B™) treatment for mild Alzheimer’s disease and provides indications of efficacy in combating decline of brain volume and potentially cognitive function
  
  


• 
  
  Laromestrocel (Lomecel-B™) is, to Company’s knowledge, the first cellular therapeutic candidate to receive U.S. FDA Regenerative Medicine Advanced Therapy (RMAT) designation for Alzheimer’s disease
  
  

MIAMI, March 11, 2025 (GLOBE NEWSWIRE) --

Longeveron Inc.

(NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, today announced the publication in


Nature Medicine


of results from the CLEAR MIND Phase 2a clinical trial evaluating

laromestrocel (Lomecel-B™)

as a potential cellular therapy for mild Alzheimer’s disease (AD). The article is also available online

here

. The International Nonproprietary Names (INN) Expert Committee of the World Health Organization recently approved “laromestrocel” for the non-proprietary name of Lomecel-B™.

“This

Nature Medicine

publication reinforces laromestrocel’s safety and efficacy as a potential treatment for mild Alzheimer’s disease and paves the way for more advances in utilizing cell therapy for Alzheimer’s disease,” said

Joshua Hare

, M.D., Founder and Chief Science Officer of Longeveron. “As a mesenchymal stem cell therapy that has multiple potential mechanisms of action to address inflammatory responses in the brain, laromestrocel offers a new potential strategy to address the underlying pathology of Alzheimer’s disease without the limitations of previous therapies. Cell based therapy with MSCs is a particularly attractive treatment candidate as it encompasses pro-vascular, immunomodulatory, and tissue repair mechanisms of actions, with findings validated in a murine Alzheimer’s disease model.”

The randomized, placebo-controlled Phase 2a CLEAR MIND trial evaluated a total of 48 patients (36 were treated with laromestrocel (Lomecel-B™) and 12 received placebo) who were 60-85 years old and had a diagnosis of mild AD in accordance with National Institutes of Health – Alzheimer’s Association (NIA-AA) criteria, a Mini-Mental State Examination (MMSE) score of 18-24, and a brain MRI and positron emission tomography (PET) scan consistent with AD. The clinical trial achieved its primary safety and secondary efficacy endpoints, and the study results being accepted for publication in

Nature Medicine

support the therapeutic potential of laromestrocel (Lomecel-B™).

Key findings include:

• 
  The trial safety evaluations supported that laromestrocel (Lomecel-B™) is safe and well tolerated in the study population, in both single and multiple dosing regimens, and that patients showed no incidence of hypersensitivity, infusion-related reactions, and no cases of amyloid-related imaging abnormalities (ARIA).
  


• 
  Patients treated with laromestrocel (Lomecel-B™) showed an overall slowing of disease worsening compared to placebo.
  


• 
  Positive efficacy results were demonstrated via a change from baseline at week 39 of the trial at prespecified levels using the Composite Alzheimer’s Disease Score (CADS) – a secondary outcome measure that combines information across cognitive, functional capacity, and brain MRI domains.
  


• 
  Administration of laromestrocel (Lomecel-B™) was associated with slowing cognitive and functional decline as demonstrated by statistically significant results in the Montreal Cognitive Assessment and statistical trending improvements compared to placebo in CDR-SB and MMSE.
  


• 
  There was a statistically significant improvement relative to placebo observed in the Alzheimer’s Disease Cooperative Study Activities of Daily Living (ADCS-ADL).
  


• 
  Patients treated with laromestrocel (Lomecel-B™) showed minimized loss in brain volume in areas associated with AD (total brain volume, Hippocampus, Temporal and Frontal lobes, and Thalamus), statistically significant relative to placebo. Along with positive changes in brain volumes, there was 20-30% reduction in left and right ventricular enlargement, respectively.
  


• 
  Diffusion tensor imaging (a form of MRI) supports the concept that laromestrocel (Lomecel-B™) has the potential to reduce neuroinflammation compared to placebo.
  


• 
  Laromestrocel (Lomecel-B™) treated patients demonstrated a numerical improvement relative to placebo in quality of life observed by caregivers and measured by the Alzheimer’s Disease Related Quality of Life (ADRQOL) and Quality of life AD (QOL-AD) scales.
  

“Alzheimer’s disease is a disorder of neurocognition with a major unmet medical need. We believe these results provide important validation of both the safety and therapeutic potential of laromestrocel in the treatment of mild Alzheimer’s disease and suggest, with further clinical evaluation, that this cellular therapy has the potential to have a positive impact on patients afflicted with this devastating disease,” said

Nataliya Agafonova

, M.D., Chief Medical Officer at Longeveron. “We look forward to our planned meeting with the FDA in March to review this data and discuss the future development path for laromestrocel (Lomecel-B™) in Alzheimer’s disease.”

The FDA has granted laromestrocel (Lomecel-B™) both

Regenerative Medicine Advanced Therapy (RMAT)

designation and

Fast Track

designation for the treatment of mild Alzheimer’s disease, which allow greater access to the FDA during laromestrocel’s (Lomecel-B™) development for Alzheimer’s disease.

About laromestrocel (Lomecel-B™)



Laromestrocel is a living cell product made from specialized cells isolated from the bone marrow of young healthy adult donors. These specialized cells, known as mesenchymal stem cells (MSCs), are essential to our endogenous biological repair mechanism. MSCs have been shown to perform a number of complex functions in the body, including the formation of new tissue. They also have been shown to respond to sites of injury or disease and secrete bioactive factors that are immunomodulatory and regenerative. We believe that laromestrocel may have multiple potential mechanisms of action that may lead to anti-inflammatory, pro-vascular regenerative responses, and therefore may have broad application for a range of rare and aging related diseases.

About Longeveron Inc


.



Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Company’s lead investigational product is laromestrocel (Lomecel-B™), an allogeneic mesenchymal stem cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Laromestrocel (Lomecel-B™) has multiple potential mechanisms of action encompassing pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair and healing effects with broad potential applications across a spectrum of disease areas. Longeveron is currently pursuing three pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer’s disease, and Aging-related Frailty. Laromestrocel (Lomecel-B™) development programs have received five distinct and important FDA designations: for the HLHS program - Orphan Drug designation, Fast Track designation, and Rare Pediatric Disease designation; and, for the AD program - Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation. For more information, visit

www.longeveron.com

or follow Longeveron on

LinkedIn

,

X

, and

Instagram

.

Forward-Looking Statements



Certain statements in this press release that are not historical facts are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which reflect management’s current expectations, assumptions, and estimates of future operations, performance and economic conditions, and involve known and unknown risks, uncertainties, and other important factors that could cause actual results, performance, or achievements to differ materially from those anticipated, expressed, or implied by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as “anticipate,” “believe,” “contemplate,” “continue,” “could,” “estimate,” “expects,” “intend,” “looks to,” “may,” “on condition,” “plan,” “potential,” “predict,” “preliminary,” “project,” “see,” “should,” “target,” “will,” “would,” or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects and include, but are not limited to, statements about the various below-listed factors. Factors that could cause actual results to differ materially from those expressed or implied in any forward-looking statements in this release include, but are not limited to, our cash position and need to raise additional capital, the difficulties we may face in obtaining access to capital, and the dilutive impact it may have on our investors; our financial performance, and ability to continue as a going concern; the period over which we estimate our existing cash and cash equivalents will be sufficient to fund our future operating expenses and capital expenditure requirements; 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, and the reporting of data from those studies and trials; the size of the market opportunity for certain of our product candidates, including our estimates of the number of patients who suffer from the diseases we are targeting; our ability to scale production and commercialize the product candidate for certain indications; the success of competing therapies that are or may become available; the beneficial characteristics, safety, efficacy and therapeutic effects of our product candidates; our ability to obtain and maintain regulatory approval of our product candidates in the U.S. and other jurisdictions; our plans relating to the further development of our product candidates, including additional disease states or indications we may pursue; 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; the need to hire additional personnel and our ability to attract and retain such personnel; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing.

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 Securities and Exchange Commission, including Longeveron’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission on February 28, 2025, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. The Company operates in highly competitive and rapidly changing environment; therefore, new factors may arise, and it is not possible for the Company’s management to predict all such factors that may arise nor assess the impact of such factors or the extent to which any individual factor or combination thereof, may cause results to differ materially from those contained in any forward-looking statements. The forward-looking statements contained in this press release are made as of the date of this press release based on information available as of the date of this press release, are inherently uncertain, 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.

Investor Contact:



Derek Cole


Investor Relations Advisory Solutions



derek.cole@iradvisory.com

Media Contact:



Steven Weiss


Rubenstein Public Relations



sweiss@rubensteinpr.com



212.805.3062

Photos accompanying this announcement are available at

https://www.globenewswire.com/NewsRoom/AttachmentNg/e9e96d9c-d6c3-4aec-ba85-36631b520211

https://www.globenewswire.com/NewsRoom/AttachmentNg/f106bde7-972a-4687-a91e-03e924f409fc

The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.