- New clinical data showed that Lomecel-B™ improved cognitive function in multiple measures in a dose-response fashion
- Caregiver ratings documented improved quality of life in Lomecel-B™ treated patients
- MRI Biomarker study data showed that Lomecel-B™ countered loss of brain volume in multiple areas associated with Alzheimer’s disease, reduced brain neuroinflammation and improved cerebral blood flow
- Overall results confirmed the drug product’s therapeutic potential in the treatment of mild Alzheimer’s disease and support further development
MIAMI, Dec. 20, 2023 (GLOBE NEWSWIRE) -- Longeveron Inc. (NASDAQ: LGVN) (“Longeveron” or “Company”), a clinical stage biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions such as hypoplastic left heart syndrome (HLHS), Alzheimer’s disease and Aging-related Frailty, today announces additional new clinical and biomarker results from its Phase 2a CLEAR MIND trial of its investigational product Lomecel-B™ for the treatment of mild Alzheimer’s disease.
The expanded data set reinforced the earlier top-line findings showing that the primary safety endpoint was met and provided further support for Lomecel-B’s positive benefit/risk profile. Additional analysis of cognitive function and daily living data consistently showed favorable results with Lomecel-B™ over placebo in a dose-response fashion, with administration of Lomecel-B™ associated with slowing and in some cases improving certain measurements of cognitive function (MoCA, MMSE). New analyses of imaging data measured using MRI showed that administration of Lomecel-B™ was associated with reduced neuroinflammation assessed by Diffusion Tensor Imaging (DTI), and also appeared to counter loss in brain volume in areas associated with Alzheimer’s disease (TBV, hippocampus, ventricles, thalamus).
Wa’el Hashad, CEO of Longeveron, commented: “These new data support our initial results for CLEAR MIND that we announced in October and provide further validation of both the safety and therapeutic potential of Lomecel-B™ in the treatment of mild Alzheimer’s disease. We believe these new data may provide evidence for Lomecel-B’s mechanism of action and add to the robust foundation we are building for its further investigation in Alzheimer’s disease as well as other indications. We anticipate presenting the CLEAR MIND results in a major medical meeting in 2024.”
Summary of new findings:
The latest data further supports the prior findings regarding Lomecel-B’s potential prevention of cognitive decline and improvement in quality of life. In addition to these clinical findings, brain imaging showed improvement in brain architecture measured by volumetric MRI and DTI, respectively.
- Lomecel-B™ (25M x 1 dose, p=0.009) and the pooled treatment group (25M x 1 dose, 25M x 4 doses, 100M x 4 doses, p=0.015) demonstrated statistically significant improvements in the Montreal Cognitive Assessment (MOCA), relative to placebo
- Lomecel-B™ demonstrated a dose-response improvement in Mini-Mental State Examination (MMSE) relative to baseline (mean + SD increase: 3.0+3.6 at highest dose, 39 weeks, p=0.028)Lomecel-B™ (100M x 4 doses) demonstrated a higher level of improvement in quality of life observed by caregiver and measured by Alzheimer’s Disease Related Quality of Life scale (ADRQOL).
Neuronal loss in Alzheimer’s disease leads to a common feature of disease such as progressive atrophy resulting in reduction in brain volume and cortical thickness that can be measured with volumetric MRI. Brain tissue loss begins with reduction in temporal lobes structures such as hippocampus followed by atrophy in other parts of the brain (parietal, frontal).
- Lomecel-B™ (100M x 4 doses) reduced the whole brain volume loss by 49% (p=0.034)Lomecel-B™ (25M x 1 dose, p=0.015) and the pooled treatment group (25M x 1 dose, 25M x 4 doses, 100M x 4 doses, p=0.038) demonstrated statistically significant reductions in left hippocampal volume loss at Week 39 relative to placebo (Degree of reduction was 84% for 25M x 1 dose).
- Brain volume preservation in the Lomecel-B™ (100M x 4 dose) dose group was accompanied by 20% and 33% reduction in left and right ventricular enlargement at Week 39 compared to placebo, respectively.
- The level of neuroinflammation measured by DTI was lower in all Lomecel-B™ doses at Week 39 compared to placebo.
Taken together, the Company believes the results of the CLEAR MIND study build a strong foundation for further development in mild Alzheimer's disease patients.
CLEAR MIND Results:
Overall, Lomecel-B™ appeared to demonstrate a positive benefit/risk profile. The primary endpoint of safety was met based on statistical and medical assessment.
The study safety data were consistent with an established safety profile with no incidence of hypersensitivity, infusion-related reactions, no cases of Alzheimer Related Imagine Abnormalities of Edema (ARIA-E) or microhemorrhages and superficial siderosis (ARIA-H) on Magnetic Resonance Imaging (MRI), and no notable changes in laboratory evaluations and electrocardiogram (EKG).
The secondary endpoint of change from baseline to Week 39 in CADS, demonstrated positive results, at the prespecified statistical level of p