Clinical TrialMay 15, 2026, 08:02 AM
Inmune Bio's XPro Phase 2 Alzheimer's trial results published
AI Summary
INmune Bio Inc. announced the publication of positive results from its Phase 2 MINDFuL trial of XPro™ in Alzheimer’s disease in the peer-reviewed journal NPJ Dementia. The study demonstrated directionally consistent benefits across multiple cognitive, functional, behavioral, and biomarker endpoints in a pre-specified Alzheimer’s Disease with inflammation (ADi) subgroup over 24 weeks, with no observed amyloid-related imaging abnormalities (ARIA). These findings, including effect sizes up to 0.27, support an inflammation-enriched strategy for future studies and strengthen the value of the XPro platform, which also holds FDA Fast Track designation.
Key Highlights
- Phase 2 MINDFuL trial results for XPro™ in Alzheimer’s disease published in NPJ Dementia.
- Pre-specified ADi subgroup showed consistent benefit across cognitive, global, functional, behavioral, and biomarker endpoints.
- Enriched subpopulation (n=100) with amyloid-beta positivity and inflammation biomarkers showed positive trends.
- Effect sizes (Cohen’s d) up to 0.27 observed across cognitive, behavioral, and biomarker endpoints.
- No amyloid-related imaging abnormalities (ARIA) were observed during the 24-week trial.
- Findings support prioritizing the enriched population for future Phase 3 studies.
- XPro™ has FDA Fast Track designation for Alzheimer’s disease with inflammation (ADi).
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