INmune Bio reports findings from Phase 2 MINDFuL trial of XPro

INmune Bio (INMB) announced results from its Phase 2 MINDFuL trial evaluating XPro, a selective soluble TNF inhibitor, in early AD with biomarkers of inflammation. Despite showing no effects in the modified intent-to-treat population, predefined analyses demonstrated a cognitive benefit for XPro over placebo on the primary endpoint EMACC, a behavioral benefit on the Neuropsychiatric Inventory, and a biological benefit on pTau217 in early Alzheimer’s patients with two or more biomarkers of inflammation at baseline, marking a key milestone in the development of XPro for Early AD. Key Findings in the Amyloid positive Early AD participants with two or more biomarkers of inflammation: Cognition: A clinical benefit of XPro over placebo was observed on the primary endpoint EMACC and on the secondary endpoint Neuropsychiatric Inventory. Alzheimer’s Disease Biomarkers: A biological benefit of XPro over placebo was observed in blood levels of pTau217, the gold standard measure of AD pathology in blood. Safety and tolerability: XPro treatment was safe and well tolerated, without any occurrences of ARIA-E or ARIA-H. Injection site reactions were common. Novel mechanism of action: This study demonstrates that it is possible to safely target neuroinflammation in patients where neuroinflammation is a driver of AD pathology. With the increased interest in inflammation as a disease-modifier in AD and neurodegeneration, these results provide the basis for further development of XPro in neurodegeneration.