Clinical TrialJun 2, 2026, 08:01 AM
Inmune Bio XPro™ Phase 2 Alzheimer's Trial Shows Significant Myelin Effect
AI Summary
Inmune Bio announced positive results from exploratory chi-separation MRI imaging analyses of its XPro™ (XPro1595) Phase 2 MINDFuL clinical trial for early Alzheimer's disease. The trial demonstrated a highly significant treatment effect on myelin in the full mITT population (p=0.0028; d=0.46) and further strengthened in biomarker-enriched patients (p=0.0098; d=0.59). These findings support the company's precision-medicine approach and align with the FDA-aligned Phase 2b/3 registrational program, which recently received Fast Track designation. The company plans to present the complete dataset at AAIC 2026.
Key Highlights
- XPro™ Phase 2 trial showed significant myelin treatment effect (p=0.0028; d=0.46) in 200 patients.
- Treatment effect strengthened in 100 biomarker-enriched patients (p=0.0098; d=0.59).
- FDA granted Fast Track designation for XPro™ in early Alzheimer's on May 14, 2026.
- FDA End-of-Phase 2 alignment secured for integrated Phase 2b/3 registrational pathway.
- No observed ARIA-E or ARIA-H, indicating a favorable safety profile.
- Complete chi-separation dataset to be presented at AAIC 2026 (July 12–15).
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