INmune Bio Inc. (INMB) announced new exploratory MRI imaging from its Phase 2 MINDFuL trial of XPro in patients with early Alzheimer's disease, showing a statistically significant treatment effect on advanced white matter imaging biomarkers.
Alzheimer's disease is marked not only by gray matter pathology but also by white matter degeneration and myelin loss, which are increasingly recognized as early contributors to cognitive decline. Preserving white matter integrity is considered critical to slowing disease progression.
In the MINDFuL study, chi-separation MRI revealed that XPro-treated patients demonstrated a significant improvement in myelin compared to placebo across the full modified intent-to-treat population (p=0.0028; Cohen's d=0.46; n=200). In biomarker-enriched patients with elevated inflammation (n=100), the effect strengthened further (p=0.0098; Cohen's d=0.59; n=100), validating INmune's precision-medicine approach.
Company executives emphasized the consistency of results across cognition, neuropsychiatric symptoms, blood biomarkers, patient-reported outcomes, and now both gray matter and white matter imaging. CEO David Moss noted that targeting neuroinflammation to preserve white matter provides a robust mechanistic foundation for XPro's registrational program and broader pipeline potential.
The company will present the complete dataset at the Alzheimer's Association International Conference (AAIC) 2026 in London, including longitudinal analyses and subgroup characterizations.
INmune Bio has secured FDA Fast Track designation and End-of-Phase 2 alignment for a seamless Phase 2b/3 registrational program in early Alzheimer's disease patients with inflammatory biomarkers. The Phase 3 portion is expected to evaluate definitive clinical outcomes using the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) as the primary endpoint.
XPro1595 is a next-generation cytokine modulator that selectively neutralizes soluble TNF to reduce neuroinflammation while preserving protective immune functions.
INMB has traded between $1.09 and $11.64 over the past year. The stock is currently trading at $1.46, up 5.38%.
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