Core Insights - INmune Bio, Inc. has submitted a manuscript detailing the results of its Phase 2 MINDFuL trial for XPro1595, a selective soluble TNF neutralizer, in early Alzheimer's disease with inflammation [1][2] - The trial did not meet its primary endpoint in the overall population, but showed promising results in a prespecified subgroup with amyloid pathology and high inflammatory burden [2][3] - The company anticipates regulatory feedback from the FDA in the first quarter of 2026 regarding the trial results [3] Company Overview - INmune Bio is a clinical-stage biotechnology company focused on developing treatments that target the innate immune system [5] - The company has three product platforms: DN-TNF, CORDStrom™, and INKmune®, each targeting different diseases and mechanisms [5] Product Insights - XPro1595 is a next-generation TNF inhibitor that selectively neutralizes soluble TNF without affecting trans-membrane TNF or TNF receptors, potentially reducing neuroinflammation in neurological diseases [4][6] - The trial results indicate that XPro1595 may benefit a specific subset of Alzheimer's patients, supporting its development as a precision medicine approach [6] Safety Profile - XPro1595 demonstrated a favorable safety profile, with no amyloid-related imaging abnormalities (ARIA) observed, distinguishing it from other treatments [6]
INmune Bio Announces Submission of Phase 2 MINDFuL Trial Results in Alzheimer’s Disease to npj Dementia, a Nature Portfolio Journal