Longeveron has revealed that the Phase IIa CLEAR MIND clinical trial of Lomecel-B for treating mild Alzheimer’s disease met its primary safety and secondary efficacy endpoints.
The placebo-controlled, randomised trial enrolled 48 participants aged between 60 and 85 years with mild Alzheimer’s disease.
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The trial indicated that the treatment with Lomecel-B could potentially slow disease progression.
Furthermore, Lomecel-B was found to be safe for both single and multiple dosing regimens, without any cases of hypersensitivity or infusion-related reactions and amyloid-related imaging abnormalities (ARIA) observed.
Patients receiving Lomecel-B also showed a general slowing of disease worsening compared to the placebo arm.
The therapeutic potential of Lomecel-B was supported by changes from baseline at week 39 in the Composite Alzheimer’s Disease Score (CADS), which includes cognitive, functional capacity, and brain MRI measurements.
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By GlobalDataSignificant statistical results were noted in the Montreal Cognitive Assessment for patients treated with Lomecel-B, with trends indicating improvements in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) and the Mini-Mental State Examination (MMSE) versus placebo.
The Alzheimer’s Disease Cooperative Study Activities of Daily Living (ADCS-ADL) scale also showed a statistically significant improvement relative to placebo.
The US Food and Drug Administration (FDA) previously awarded Lomecel-B both regenerative medicine advanced therapy and fast-track designations for mild Alzheimer’s disease treatment.
Longeveron co-founder, chief science officer and chairman Joshua Hare said: “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.
“We look forward to meeting the FDA to review this data and discuss the future development path for Lomecel-B in Alzheimer’s disease.”
