Clinical TrialJun 2, 2026, 04:03 PM
INmune Bio: XPro™ Shows Significant White Matter Effect in Alzheimer's Trial
AI Summary
INmune Bio announced positive results from exploratory chi-separation MRI imaging analyses from its Phase 2 MINDFuL clinical trial of XPro™ (XPro1595) in patients with early Alzheimer's disease. The results showed a statistically significant treatment effect on white matter, particularly in patients with elevated inflammation, supporting the company's precision-medicine strategy. The company has also secured FDA alignment on an integrated Phase 2b/3 registrational pathway and received Fast Track designation for XPro™.
Key Highlights
- INmune Bio reports statistically significant treatment effect on advanced white matter MRI biomarker in Phase 2 MINDFuL Alzheimer's trial.
- XPro1595 showed a statistically significant treatment effect in the full mITT population (p=0.0028; d=0.46; n=200).
- Efficacy was strengthened in biomarker-enriched patients with elevated inflammation (p=0.0098; d=0.59; n=100), validating precision-medicine approach.
- Chi-separation MRI analysis demonstrated a treatment effect on myelin in the full study population, strengthening in patients with elevated inflammatory biomarkers.
- FDA End-of-Phase 2 alignment achieved for an integrated Phase 2b/3 registrational pathway.
- FDA Fast Track designation granted for XPro™ in early Alzheimer's disease.
- The company will present complete chi-separation dataset at AAIC 2026.
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