Core Insights - INmune Bio Inc. announced additional analyses from its Phase 2 MINDFuL trial for XPro™, a selective soluble TNF inhibitor, to be presented at the Alzheimer's Association International Conference in Toronto on July 29, 2025 [1] - The MINDFuL trial is a double-blind, Phase 2 proof-of-concept study aimed at evaluating XPro™'s potential to slow cognitive decline in early-stage Alzheimer's disease by targeting neuroinflammation [2] - Although the primary endpoint was not met in the overall modified-intent-to-treat group, significant benefits were observed in a subpopulation with confirmed amyloid-beta pathology and systemic inflammation biomarkers [3] Study Details - The MINDFuL trial enrolled 208 participants with early Alzheimer's disease, requiring at least one biomarker of inflammation [2][6] - Participants received XPro™ or placebo in a 2:1 ratio for 24 weeks, with cognitive changes measured using the Early Mild Alzheimer's Cognitive Composite [2][6] - The trial's findings suggest a potential therapeutic approach for Alzheimer's by targeting inflammation [4] Future Plans - INmune Bio plans to submit a publication of the MINDFuL Phase 2 study results by mid-August [4] - The company is seeking strategic partnerships to expedite the development of XPro™ for Alzheimer's treatment [4] Product Information - XPro™ is designed to inhibit soluble TNF while preserving trans-membrane TNF and TNF receptors, potentially enhancing cognitive function and neuronal communication [7] - INmune Bio focuses on developing treatments that target the innate immune system, with XPro™ being part of its Dominant-Negative Tumor Necrosis Factor product platform [8][9]

Core Insights - The Phase 2 MINDFuL trial of XPro™ in early Alzheimer's Disease (AD) patients with inflammation biomarkers did not meet the primary cognitive endpoint in the modified intent-to-treat (mITT) population, but showed cognitive, behavioral, and biological benefits in a predefined subgroup of amyloid-positive patients with two or more inflammation biomarkers [1][3][4] Group 1: Trial Results - The MINDFuL trial enrolled 208 participants with early-stage AD, assessing XPro™'s potential to slow cognitive decline by targeting neuroinflammation [4] - In the predefined subgroup of amyloid-positive early AD patients with two or more inflammation biomarkers (n=100), XPro™ demonstrated a cognitive benefit on the primary endpoint EMACC (effect size: 0.27) and a behavioral benefit on the Neuropsychiatric Inventory (effect size: -0.24) [7] - A biological benefit was observed in blood levels of pTau217 (effect size: -0.20), indicating a positive impact on AD pathology [7] Group 2: Safety and Tolerability - XPro™ treatment was well-tolerated and safe, with no occurrences of ARIA-E or ARIA-H reported [2][7] - The most common adverse events were injection site reactions, occurring in 80% of the XPro™ group compared to less than 20% in the placebo group [7] - There were no deaths or drug-related hospitalizations during the trial, indicating a favorable safety profile [7] Group 3: Future Plans - The company plans to submit for Breakthrough Therapy designation with the FDA and will present additional analyses at the Alzheimer's Association International Conference (AAIC) in July 2025 [2][10] - The company aims to engage regulatory authorities in the UK, EU, and other regions to define the path for a pivotal trial to support XPro™ approval in early AD [14]

Conference Call Today at 4:30pm ETBOCA RATON, Fla., May 08, 2025 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ: INMB) (the “Company”), a clinical-stage biotechnology company targeting inflammation and immunology through the innate immune system, today announces its financial results for the quarter ended March 31, 2025 and provides a business update. Q1 2025 and Recent Corporate Highlights DN-TNF Platform Highlights (XPro™): Top-line results from the MINDFuL phase 2 trial in Alzheimer’s expected in the secon ...