Longeveron announces new clinical, biomarker results from Phase 2a CLEAR MIND

Longeveron 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. 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 and the pooled treatment group demonstrated statistically significant improvements in the Montreal Cognitive Assessment, relative to placebo. Lomecel-B demonstrated a dose-response improvement in Mini-Mental State Examination relative to baseline. Lomecel-B demonstrated a higher level of improvement in quality of life observed by caregiver and measured by Alzheimer’s Disease Related Quality of Life scale. Lomecel-B reduced the whole brain volume loss by 49%. Lomecel-B and the pooled treatment group demonstrated statistically significant reductions in left hippocampal volume loss at Week 39 relative to placebo. Brain volume preservation in the Lomecel-B 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. 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 or microhemorrhages and superficial siderosis on Magnetic Resonance Imaging, and no notable changes in laboratory evaluations and electrocardiogram. The secondary endpoint of change from baseline to Week 39 in CADS, demonstrated positive results: Statistically significant improvement at Week 39 in CADS was observed for the Lomecel-B 25 x 106 cells x 1 dose versus placebo and for the pooled Lomecel-B Groups. In terms of the specific components of the CADS score: Lomecel-B demonstrated statistically significant slowing of disease progression in left hippocampal volume relative to placebo. ADCS-ADL and left hippocampal volume at Week 39 were statistically significant for the pooled Lomecel-B treatment groups relative to placebo. Other doses demonstrated numerical slowing and prevention of disease worsening relative to placebo in CADS, ADAS-cog-13, CDR-SB, ADCS-ADL and left hippocampal volume at Week 39