INmune Bio's XPro (pegipanermin), a brain-penetrant tumour necrosis factor (TNF) inhibitor, missed the primary endpoint in the Phase II MINDFuL trial (n=200) for early Alzheimer's disease (AD), showing no significant difference in Early Mild AD Cognitive Composite (EMACC) scores versus placebo at 24 weeks. However, prespecified subgroup analyses revealed potential benefits in amyloid-positive patients with ≥2 inflammatory biomarkers, demonstrating favourable effects on cognition (effect size 0.27), neuropsychiatric symptoms (−0.24) and blood pTau217 levels (−0.20).

XPro exhibited a safety profile consistent with prior studies, with injection-site reactions (80%) as the most common adverse event. INmune Bio plans to discuss a pivotal trial pathway with regulatory authorities in its US homeland in Q4 2025, citing consistent signals across clinical and biomarker endpoints. Full results will be presented at the Alzheimer's Association International Conference (AAIC) 2025.