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INmune Bio Announces Results of Additional Blinded Interim Analysis of Phase 2 Alzheimer's Disease Trial Demonstrating Correlation between EMACC and CDR-SB Endpoints
INmune BioINmune Bio(US:INMB) GlobeNewswire News Roomยท2024-09-17 12:30

Core Insights - INmune Bio Inc. announced exceptional performance of the EMACC cognitive measure in its AD02 Phase II Alzheimer's Disease trial, showing a significant correlation with the CDR-SB endpoint [1][3][4] Group 1: EMACC Performance - The analysis confirmed a highly significant correlation (p<0.001) between baseline scores on EMACC and CDR-SB, which is the most commonly used clinical rating scale in Alzheimer's Disease registration studies [3] - EMACC demonstrated a reliability correlation of 0.93 when measured during screening and at the first study visit before treatment, indicating high precision and robustness [3] - EMACC effectively differentiated between patients with prodromal AD (CDR global rating of 0.5) and mild dementia (CDR rating of 1.0), with an effect size (Cohen's d) of 0.87 (p<.0001) [3] Group 2: Clinical Trial Insights - The novel design elements in the AD02 Phase II trial are believed to significantly de-risk the clinical program compared to traditional trial designs in Alzheimer's drug development [4] - EMACC is positioned as the primary endpoint in the trial, which aims to measure cognitive changes in early AD patients with biomarkers of inflammation [4] - Enrollment is expected to be completed by the end of the current quarter, with topline data anticipated approximately six months after the last patient is enrolled [4] Group 3: About EMACC - EMACC is an empirically derived cognitive measure that combines standardized neuropsychological tests, showing the greatest sensitivity to change in early Alzheimer's Disease patients over two years [5] - The performance characteristics of EMACC were first reported by Biogen at CTAD in 2021 and were found to be strongly associated with biological markers of inflammation [5] Group 4: Company Overview - INmune Bio Inc. is a clinical-stage biotechnology company focused on developing treatments targeting the innate immune system to combat diseases [9] - The company has two product platforms in clinical trials: the DN-TNF product platform and the Natural Killer Cell Priming Platform, aimed at treating various diseases including cancer and chronic inflammation [9]