INmune Bio submits Phase 2 MINDFuL trial results to npj Dementia

INmune Bio (INMB) announces the submission of a manuscript detailing the results of its Phase 2 MINDFuL trial. The manuscript, titled, “XPro1595, a Selective Soluble TNF Neutralizer, in Early Alzheimer’s Disease with Inflammation: Results from the Phase 2 MINDFuL Trial,” has been submitted for peer review to npj Dementia, a Nature Portfolio journal. The detailed manuscript provides a comprehensive analysis of the trial, which evaluated the safety and efficacy of XPro in patients with early Alzheimer’s disease and biological signs of inflammation. While the study did not meet its primary endpoint in the overall population, the findings reveal a promising signal in a prespecified subgroup of patients with both amyloid pathology and a high inflammatory burden, defined by two or more biomarkers of inflammation, referred to as the ADi population. Key findings within the biomarker-enriched ADi population include: XPro demonstrated consistent positive trends across cognitive, neuropsychiatric, and biological endpoints, which suggests that targeting neuroinflammation by selectively neutralizing soluble TNF may offer benefits for a specific subset of individuals living with Alzheimer’s disease, supporting continued development of XPro as a precision medicine approach for this patient group; Complete absence of amyloid-related imaging abnormalities, a serious side effect commonly associated with amyloid-targeting therapies. This favorable safety profile was observed in a high-risk patient population, including significant numbers of APOE4 carriers, patients receiving anticoagulant medications, and individuals with multiple cerebral microbleeds. This distinguishes XPro from other treatments and suggests its potential for broader use, including in combination therapies. “Data in the subgroup analysis strongly suggests XPro will benefit the trial’s target patient population while also providing a strong rationale for our upcoming end-of-Phase 2 discussions with regulatory authorities, including the FDA, EMA, and MHRA,” stated David Moss, CEO of INmune Bio. “We anticipate receiving regulatory feedback from the FDA in the first quarter of 2026.”