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INmune Bio, Inc. Completes Blinded Interim Analysis of Phase II Alzheimer’s Disease Trial
The planned interim analysis confirms the accuracy of the sample size calculations and statistical power for EMACC, the primary endpoint. The interim
About this update from Inmune Bio Inc.
[{"type":"text","content":"The planned interim analysis confirms the accuracy of the sample size calculations and statistical power for EMACC, the primary endpoint. The interim analysis, performed by a third-party, demonstrated no need to change trial design or size. BOCA RATON, Fla., June 27, 2024 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, today confirmed the Phase II Alzheimer’s Disease clinical trial, AD02, is appropriately powered following a blinded sample size re-estimation using the trial’s primary endpoint, the Early Mild Alzheimer’s Cognitive Composite (EMACC). The third-party evaluation concluded that the trial design, operational execution, data collection, and management are of the highest quality. INmune Bio commissioned a third-party group of statisticians and neuropsychologists to evaluate the interim data of patients who completed the 6-month trial. The main goal of the blinded analysis was to evaluate the power and performance characteristics of the primary endpoint, the EMACC. The EMACC is an empirically validated cognitive measure composed of standardized and widely used neuropsychological tests that are ideally suited for use in clinical trials in Early Alzheimer’s Disease (AD). Compared to CDR-SB and ADAS-Cog for example, the EMACC is an objective measure of cognitive function that accurately captures cognitive changes that occur during early AD. The performance characteristics of the EMACC in early AD were first reported by Biogen at CTAD in 2021 (LBR05) where it was successfully applied to measure cognitive decline in the Biogen Tango Study of the gosenuremab program (BIIB092). Notably, EMACC was also found to be strongly associated with biological markers of inflammation in the Alzheimer’s Diesase Neuroimaging Initiative (ADNI) AD study; which was used to compute the statistical power for AD02. “As this is the first trial to feature the EMACC as a primary endpoint, this interim analysis by a third party was critical to ensure that the EMACC is performing as intended,” says CJ Barnum, PhD, VP of Neuroscience at INmune Bio. “The results presented to the Company from this blinded analysis were extremely encouraging.” “As a neuropsychologist that has worked in industry for more ...