Longeveron Announces Presentation of Clinical Data at the 2026 Alzheimer’s Association International Conference (AAIC) that Indicate Its Cellular Therapy Laromestrocel Reduced Neuroinflammation in Patients with Alzheimer’s Disease
- Poster Presentation at the 2026 Alzheimer’s Association International Conference (AAIC) entitled "Laromestrocel Stabilizes Brain Inflammation In Key Alzheimer’s Disease Gray And White Matter Regions As Assessed Using Free Water MRI" presented at July 13th In Person Poster Presentation Session
- Results support a clinically relevant and long-lasting anti-inflammatory mechanism of action of laromestrocel in gray and white matter of the brain, indicate potential blood biomarker correlates with clinical outcomes, and support continued clinical development of laromestrocel for Alzheimer’s disease
- Longeveron has received U.S. FDA RMAT designation for its Alzheimer’s disease program and has aligned on a Phase 3 study design
MIAMI, July 13, 2026 (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 additional analysis of data from the Phase 2a clinical trial evaluating its stem cell therapy laromestrocel in mild Alzheimer’s disease (AD) is being presented in a Poster Presentation at the 2026 Alzheimer’s Association International Conference® (AAIC®), being held July 12-15, 2026 in London, United Kingdom and online.
Results presented in "Laromestrocel Stabilizes Brain Inflammation In Key Alzheimer’s Disease Gray And White Matter Regions As Assessed Using Free Water MRI" provide support for a clinically relevant and durable anti-inflammatory mechanism of action of laromestrocel in gray and white matter and indicate potential blood biomarker correlates. Importantly, the reduction on free water detected by MRI correlates with both improved clinical outcomes and the anti-atrophic responses in the brain.
A key contributor to AD brain atrophy and clinical pathology is progressive neuroinflammation, and no therapeutic to date has been successful in mitigating the destructive inflammation of AD. Brain inflammation can be indexed using free water MRI. Longeveron previously found that free water rose substantially during AD pathogenesis in the brains of individuals in the placebo group, particularly in the hippocampus, temporal lobe, and other key AD regions, but subjects treated with laromestrocel showed no increase. Together with previously published data, these results showed that laromestrocel, a human bone marrow-derived, mesenchymal stem cell therapy with anti-inflammatory and pro-vascular effects, substantially reduced brain atrophy and lowered free water in a proof of concept, randomized Phase 2a trial (CLEAR-MIND).
In this new post-hoc exploratory analysis of CLEAR-MIND results, the anti-inflammatory effect was observed to be most prominent in the hippocampus, temporal lobe, and other AD-associated areas and correlated (Spearman) with both increased brain volume and improved cognitive and quality of life scores.
Laromestrocel infusion groups were: 1) placebo, 2) 25 million cells, single dose (25Mx1), 3) 25M cells over 4 monthly doses (25Mx4) or 4) 100M cells over 4 monthly doses (100Mx4), vs placebo. Data were statistically modeled using Mixed Model Repeated Measures (MMRM). In the placebo population (N=10), free water rose over 39 weeks in key white matter regions: the fornix, sagittal stratum, uncinate fasciculus. However, free water was numerically reduced compared with placebo in all groups receiving laromestrocel (fornix at week 26: 25Mx4, N=11, p=0.058; sagittal stratum at week 39: pooled 25Mx4 and 100Mx4 treatment groups, N=21, p=0.063; uncinate fasciculus (left) at week 39: 100Mx4, N=10, p=0.064). This reduction trend in free water correlated (Spearman) with Longeveron’s recent findings showing significantly reduced free water compared with placebo at 39 weeks in key gray matter regions: hippocampus, the temporal, parietal, and occipital lobes, and medulla, and with improvements in clinical scores.
Blood plasma samples from the trial were assessed using NuLISA. Plasma NuLISA indicated a reduction compared with placebo (N=11) at 39 weeks in neurogranin, a marker of neuronal degradation (25Mx4, N=12, p=0.023), and an increase in IL-13, an anti-inflammatory cytokine that regulates brain microglia activation (25Mx1, N=12, p=0.043).
"We believe these results provide important validation of the therapeutic potential of laromestrocel in the treatment of mild Alzheimer’s disease," said Joshua Hare, M.D., Co-founder, Chief Science Officer, and Executive Chairman at Longeveron. "We look forward to continuing partnering discussions to advance this potentially important new option for addressing Alzheimer’s disease."
Results from the CLEAR MIND Phase 2a clinical trial, which support the therapeutic potential of laromestrocel in the treatment of mild Alzheimer’s disease and provided evidence-based support for further clinical development, were published in the peer-reviewed journal Nature Medicine in March 2025.
The U.S. Food and Drug Administration (FDA) has granted laromestrocel 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 development for Alzheimer’s disease.
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 pursuing four pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer’s disease, Pediatric Dilated Cardiomyopathy (DCM) and Aging-related Frailty. 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, although not all forward-looking statements contain these words, 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, the ability of our clinical trials to demonstrate safety and efficacy of our product candidates, and other positive results; our ability to successfully transition toward a more capital-efficient, asset-light operating model; our ability to secure one or more strategic licensing partnerships for our stem cell therapy laromestrocel in our development programs; the ability to reach alignment with the FDA on a potential path toward regulatory approval; receipt of trial results and other available evidence sufficient to support the Company filing a BLA following the readout of top-line results of the ELPIS II data; the timing and focus of our ongoing and future preclinical studies and clinical trials, and the reporting of data from those studies and trials; market and other conditions, 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 investigational 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 investigational 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 investigational 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 investigational product candidates; our ability to obtain and maintain regulatory approval of our investigational product candidates in the U.S. and other jurisdictions; our plans relating to the further development of our investigational 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, 2025, filed with the Securities and Exchange Commission on March 17, 2026, 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
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