INmune Bio presents baseline demographics of participants in MINDFuL study

INmune Bio (INMB) is presenting a poster at the annual International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurologic Disorders taking place in Vienna, Austria April 1-5 2025. AD/PD is the largest Alzheimer’s conference in Europe. The poster details the demographics and biomarker status of patients at the time of enrollment in the MINDFul Phase II blinded, randomized trial in patients with early AD and biomarkers of inflammation. Patients enrolled in the MINDfuL trial were diagnosed with either MCI or mild AD. The average age was 72 years across both diagnostic categories. All enrolled patients met enrichment criteria for at least one of the following biomarkers of inflammation: hsCRP greater than 1.5 mg/L; ESR greater than 10 mm/hr; HbA1c greater than 6.0 %; or at least one APOE 4 allele. Patients were randomized 2:1 to receive either XPro 1.0 mg/kg or placebo by subcutaneous injection given once per week for 23 weeks. The primary endpoint in the MINDFuL trial is change from baseline in cognitive scores measured with the Early and Mild Alzheimer’s Cognitive Composite. As reported elsewhere, the EMACC was designed specifically to serve as an objective outcome measure in Early AD clinical trials. The EMACC provides improved sensitivity for detection and tracking Baseline scores on the EMACC were higher in the MCI vs mAD groups and correlated with scores on both the MMSE and CDR-SB, indicating good construct validity for the primary endpoint. The screen failure rate in the MINDfuL trial was 72%, with disease severity as measured by screening MMSE as the most common reasons for exclusion. Secondary endpoints in the MINDFuL trial include the CDR-SB, E-Cog, ADL and Neuropsychiatric Inventory instruments, along with blood biomarker and neuroimaging outcomes. Topline results of the MINDFuL trial will be reported in June 2025.