Top-line Phase IIa data has demonstrated an allogeneic stem-cell therapy facilitated a lack of deterioration in cognitive signals in mild Alzheimer’s.
Longeveron’s Phase IIa trial of its stem-cell therapy for mild Alzheimer’s has revealed in top-line results, that certain doses enabled numerical slowing/prevention of disease worsening relative to placebo.
According to Longeveron who developed the treatment, Lomecel-B™ is a living cell product made from mesenchymal stromal cells (MSCs) isolated from the bone marrow donors.
Key data from the Phase II Alzheimer’s trial
The Phase IIa CLEAR MIND trial enrolled 50 patients aged 60-85 and had a diagnosis of mild Alzheimer’s disease.
Study safety data were consistent with an established safety profile. There were no observed incidence of hypersensitivity and no cases of Alzheimer Related Imagine Abnormalities (ARIA), the data showed.
“These study results with Lomecel-B are encouraging,” stated Dr Jeffrey Cummings, Vice Chair of Research, UNLV Department of Brain Health. The study is “supported by lack of deterioration in cognitive or atrophy signals”. In addition, the efficacy observations are encouraging, Dr Cummings shared.
The secondary endpoint of change from baseline to week 39 in Composite Alzheimer’s Disease Score (CADS) demonstrated a statistically significant improvement at Week 39 in CADS for the Lomecel-B 25 x 106 cells (25M) x 1 dose versus placebo.
In terms of the specific components of the CADS score observed in the trial, Longeveron reported:
- Lomecel-B (25M x 1 dose) demonstrated statistically significant slowing of disease progression in left hippocampal volume relative to placebo
- Other doses demonstrated numerical slowing and prevention of disease worsening relative to placebo in CADS, Alzheimer’s Disease Assessment Scale-Cognitive 13 (ADAS-cog13), Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) as well as left hippocampal volume at Week 39.
These results “provide a robust foundation for additional clinical trials in this and other indications,” remarked Wa’el Hashad, Chief Executive Officer of Longeveron. Hashad added that the company is looking forward to “meaningful milestones in the near term and to fully realising the therapeutic potential of Lomecel-B.”
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