BOCA RATON, Fla., May 15, 2026
INmune Bio announced the publication of positive Phase 2 MINDFuL trial results for XPro™ (pegipanermin) in Alzheimer’s disease in the peer-reviewed journal NPJ Dementia. The study evaluated patients with mild Alzheimer’s disease characterized by inflammatory biomarkers and demonstrated directionally consistent improvements across cognitive, behavioral, functional, and biomarker endpoints, while reporting no amyloid-related imaging abnormalities (ARIA) — a major safety concern linked to several currently approved Alzheimer’s therapies.
The publication highlights findings from a pre-specified subgroup of patients with Alzheimer’s Disease with inflammation (ADi), defined by amyloid-beta positivity and elevated inflammatory biomarkers such as hsCRP, ESR, HbA1c, or APOE ε4 status. Researchers reported positive trends over 24 weeks across cognitive assessments including EMACC and International Shopping List Test, along with improvements in behavioral outcomes and patient-reported measures. Biomarker analysis also showed favorable changes in pTau217 and GFAP, supporting the biological activity of XPro™ in targeting neuroinflammation associated with Alzheimer’s progression.
Biomarker-Driven Approach Could Redefine Alzheimer’s Trials
According to INmune Bio, the MINDFuL trial is the first peer-reviewed Alzheimer’s study to prospectively identify patients using both amyloid pathology and inflammatory biomarkers. The company believes this enriched patient-selection strategy could significantly improve future Alzheimer’s clinical trial design by focusing on patients most likely to benefit from anti-inflammatory treatment approaches. The reported effect sizes reached up to 0.27 Cohen’s d, which researchers say is meaningful for a mid-stage Alzheimer’s trial targeting multiple disease domains simultaneously.
Company executives stated that the consistency observed across cognition, behavior, function, and biomarkers supports advancement toward a future Phase 3 development program. In addition, the recent FDA Fast Track designation for XPro™ further strengthens the platform’s regulatory positioning and highlights growing interest in therapies targeting neuroinflammation rather than amyloid alone.
XPro™ Targets Inflammation Without Broad Immune Suppression
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XPro™ is designed as a selective inhibitor of soluble tumor necrosis factor (sTNF), a major driver of chronic inflammation and innate immune dysfunction. Unlike conventional TNF inhibitors that broadly suppress immune activity, XPro™ specifically blocks pathological sTNF signaling through TNFR1 while preserving beneficial immune pathways mediated through TNFR2. This differentiated mechanism aims to restore immune balance in the central nervous system without compromising normal immune defense and tissue repair functions.
INmune Bio believes the broader XPro™ platform may have therapeutic potential beyond Alzheimer’s disease, including other inflammation-driven neurological and psychiatric disorders. The company is also advancing programs in treatment-resistant depression, oncology, and regenerative medicine, positioning its innate immune-focused pipeline as a differentiated approach within precision immunology.
Source: INmune Bio press release
