Lomecel-B Meets Key Objectives in Phase IIa Alzheimer’s Study

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Lomecel-B, a living cell product for the treatment of Alzheimer’s Disease, has met key primary and secondary endpoints in the Phase IIa CLEAR MIND clinical trial (NCT05233774). Among emerging, positive results from the study, Longeveron’s potential therapy showed an overall slowing of disease worsening compared to placebo.¹

According to Longeveron, key findings which were recently presented at the Alzheimer’s Association International Conference (AAIC) include:

• The established safety profile of Lomecel-B for single and multiple dosing regimens was demonstrated in study data that showed no incidence of hypersensitivity, infusion-related reactions, and no cases of amyloid-related imaging abnormalities (ARIA).
• Positive efficacy results were demonstrated via a change from baseline at week 39 of the trial at prespecified levels using the Composite Alzheimer’s Disease Score (CADS)—a secondary outcome measure that combines information across cognitive, functional capacity, and brain MRI domains.
• There was a statistically significant improvement relative to placebo observed in the Alzheimer’s Disease Cooperative Study Activities of Daily Living (ADCS-ADL).
• Lomecel-B minimized the loss in brain volume in areas associated with Alzheimer’s Disease (TBV, Hippocampus, Ventricles, Thalamus), statistically significant for left hippocampal volume relative to placebo. Along with positive changes in brain volumes, there was 20-30% reduction in left and right ventricular enlargement, respectively.

“As a medicinal signaling cell therapy that has multiple potential mechanisms of action to address inflammatory responses in the brain, Lomecel-B offers potential to address the underlying pathology of Alzheimer’s Disease without the limitations of previous therapies,” Wa’el Hashad, chief executive officer at Longeveron said in a press release. “We are very encouraged by the safety profile and efficacy evidence that support the differentiated therapeutic potential of Lomecel-B™ and lay the foundation for its future clinical development. We’re pleased to connect with the Alzheimer’s community at AAIC 2024 and contribute to the growing body of evidence that fuels the continued development of novel therapeutics for this devastating disease.”

The Phase IIa CLEAR MIND trial was a randomized, placebo-controlled study. It enrolled 48 patients who were 60-85 years old and had a diagnosis of mild Alzheimer’s Disease, a Mini-Mental State Examination (MMSE) score of 18-24, and a brain MRI and positron emission tomography (PET) scan consistent with Alzheimer’s Disease. Of the participants, 36 received Lomecel-B and 12 received placebo.

According to the Alzheimer’s Assocation, the disease is the most common cause of dementia, accounting for an estimated 60% to 80% of cases. It is also estimated that 6.9 million Americans are living with Alzheimer’s dementia.²

The FDA has granted Lomecel-B both Regenerative Medicine Advanced Therapy (RMAT) designation and Fast Track designation for the treatment of mild Alzheimer’s Disease.

“We believe these results provide important validation of both the safety and therapeutic potential of Lomecel-B in the treatment of mild Alzheimer’s Disease and suggest, with further clinical evaluation, that this cellular therapy has the potential to have a positive impact on patients afflicted with this devastating disease,” Joshua Hare, MD, co-founder, chief science officer, and chairman at Longeveron said in the press release. “We look forward to meeting the FDA to review this data and discuss the future development path for Lomecel-B™ in Alzheimer’s Disease.”

References

1. Longeveron® Presents Study Results from CLEAR MIND Phase 2a Clinical Trial of Lomecel-B™ in Mild Alzheimer’s Disease at the Alzheimer’s Association International Conference® (AAIC). News release. Longeveron. July 28, 2024. Accessed July 29, 2024. https://investors.longeveron.com/news/News/news-details/2024/Longeveron-Presents-Study-Results-from-CLEAR-MIND-Phase-2a-Clinical-Trial-of-Lomecel-B-in-Mild-Alzheimers-Disease-at-the-Alzheimers-Association-International-Conference-AAIC/default.aspx

2. 2024 Alzheimer’s Disease Facts and Figures. Alzheimer’s Association. Accessed July 28, 2024. https://www.alz.org/media/Documents/alzheimers-facts-and-figures.pdf