Longeveron New MRI Biomarker Data Linking Neuroinflammation to Clinical Outcomes in Patients with Mild Alzheimer’s Disease Presented at the Clinical Trials on Alzheimer’s Disease Conference (CTAD 2025)
Longeveron New MRI Biomarker Data Linking Neuroinflammation to Clinical Outcomes in Patients with Mild Alzheimer’s Disease Presented at the Clinical Trials on Alzheimer’s Disease Conference (CTAD 2025)
- Results obtained in the Phase 2 placebo-controlled CLEAR-MIND clinical trial showed that treatment with stem cell therapy laromestrocel was associated with a reduction in MRI measured neuroinflammation compared to placebo across multiple key brain regions, including key Alzheimer’s disease-associated regions, most notably in the hippocampus
- Reduction in hippocampal neuroinflammation, measured using MRI assessed free water, correlated strongly with preservation of hippocampal volume and with clinical outcomes
- Findings suggest a sustained anti-inflammatory effect of laromestrocel, reinforcing its proposed mechanism of action in the treatment of mild Alzheimer’s disease
MIAMI, Dec. 01, 2025 (GLOBE NEWSWIRE) — Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing cellular therapy for life-threatening, rare pediatric and chronic aging-related conditions, today announced that its submission entitled “Reduced brain neuroinflammation after laromestrocel treatment in mild AD: results from the CLEAR MIND study” is being presented in a poster presentation at the 18th Clinical Trials on Alzheimer’s Disease Conference (CTAD 2025) being held December 1-4, 2025 in San Diego, CA.
“Laromestrocel, a stem cell therapy that has multiple potential mechanisms of action to address inflammatory responses in the brain, offers the potential to address the underlying pathology of Alzheimer’s disease,” said Joshua Hare, M.D., Co-founder, Chief Science Officer, and Executive Chairman at Longeveron. “This data expands on the positive clinical information from the Phase 2a CLEAR MIND clinical trial that showed laromestrocel improved cognitive function, quality of life, and brain volume in the treatment of mild Alzheimer’s disease. We are very encouraged by the safety profile and efficacy evidence that support the differentiated therapeutic potential of laromestrocel in Alzheimer’s disease.”
Longeveron has conducted phase 1 and 2 clinical trials testing laromestrocel as a potential therapeutic for mild AD and has received Regenerative Medicine Advanced Therapy (RMAT) designation from the US Food and Drug Administration (FDA) for this clinical program.
From the Poster:
A hallmark feature of Alzheimer’s disease (AD) is neuroinflammation, which is a principal driving factor in disease pathogenesis, gliosis, and neuronal death. In the CLEAR MIND study, we demonstrated that laromestrocel treatment improved clinical scores and reduced brain atrophy in multiple brain regions, including the hippocampus as well as the temporal and frontal lobes. To extend these findings, we sought mechanistic evidence of an effect on neuroinflammation in core AD-associated regions, particularly the hippocampal and temporal regions.
We examined the effects of laromestrocel treatment in patients of our CLEAR MIND Phase 2a trial on inflammation in the AD brain using diffusion tensor imaging (DTI) and free water analysis. In DTI imaging, although mean diffusivity provides some indication of inflammation, free water is considered a more precise measure and is used in assessing hippocampal AD pathology, although no clinically meaningful difference in free water has yet been defined. Laromestrocel is a novel, bone marrow-derived, mesenchymal stem cell (MSC)-based investigational therapeutic that targets neuroinflammation, microvascular dysfunction, and has the potential to stimulate endogenous tissue regeneration, and has received RMAT and fast-track designations from the US FDA for mild AD.
Results:
Patients receiving laromestrocel exhibited a durable reduction in free water fraction compared with placebo (N=11) at week 39 for several brain regions, including hippocampus (Group 4: p=0.004, N=8; Group 3: p=0.037, N=8), which showed a dose response, and also temporal cortex (Group 3: p=0.032, N=8), occipital cortex (Group 3: p=0.003, N=8), and parietal cortex (Group 3: p=0.038, N=8). This new result was accompanied by clinical benefit as wells as reduced brain atrophy, as demonstrated in our study. Of the 14 brain regions, 13 (all but frontal) showed pooled treatment group responses (Groups 2, 3, and 4 combined) in the direction of improvement (reduction in free water) by week 39.
Poster Conclusion:
Overall, treatment with laromestrocel was associated with a reduction in neuroinflammation as assessed by free water compared to placebo across multiple brain regions, including key AD-associated regions—most notably in the hippocampus and temporal lobe. Importantly, rising free water was found in the placebo group, representing continued disease progression, while inflammation was stabilized with laromestrocel treatment. These findings suggest a sustained anti-inflammatory effect of laromestrocel, reinforcing its proposed mechanism of action in the treatment of mild Alzheimer’s disease. This evidence supports continued clinical development of laromestrocel for this indication.
Poster Presentation – Poster Session 1
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Monday, December 1, 2025, 3:00 p.m. PT to Tuesday, December 2, 2025 5:30 p.m. PT |
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11. New Therapies and Clinical Trials |
| Title: |
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00260 “Reduced brain neuroinflammation after laromestrocel treatment in mild AD: results from the CLEAR MIND study” |
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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 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 Pediatric Dilated Cardiomyopathy (DCM). Laromestrocel 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. 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 and Media Contact:
Derek Cole
Investor Relations Advisory Solutions
derek.cole@iradvisory.com
A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/f106bde7-972a-4687-a91e-03e924f409fc
