INmune Bio Inc recently announced that results from its phase 2 MINDFuL trial in Alzheimer’s Disease (AD) have been published in the peer-reviewed journal NPJ Dementia. The study evaluated the safety, biomarker engagement, and clinical efficacy of XPro (XPro1595, pegipanermin) in patients with mild AD characterised by biomarkers of inflammation.

In a pre-specified analysis of the protocol-defined Alzheimer’s Disease with inflammation (ADi) subgroup, XPro showed directionally consistent benefit across cognitive, global, functional, behavioral, and biomarker endpoints over 24 weeks, with no Amyloid-Related Imaging Abnormalities (ARIA) observed.

The publication, titled “XPro1595 in Early Alzheimer’s Disease with Inflammation: Results from the Phase 2 MINDFuL Trial,” discusses how XPro demonstrated consistent positive trends in a pre-specified enriched subpopulation (n=100) with amyloid-beta positivity and two or more inflammation biomarkers (hsCRP, ESR, HbA1c, or APOE ε4 allele).

CJ Barnum, PhD, Vice President, Neuroscience, INmune Bio, said, “MINDFuL is the first peer-reviewed trial to prospectively identify Alzheimer’s patients by both amyloid pathology and a biomarker-defined inflammatory signature. In this pre-specified subgroup, we observed directional improvements across cognitive, global, functional, behavioral, and biomarker endpoints, with no ARIA. The cross-domain consistency tracks with the underlying biology and represents the type of signal a phase 2 trial is designed to identify, forming the foundation of a phase 3 program.”

The paper further highlights the effect sizes (Cohen’s d) up to 0.27 across cognitive (EMACC, International Shopping List Test), Patient-Reported Outcomes (Goal Attainment), behavioral (Neuropsychiatric Inventory), and biomarker endpoints (pTau217 and GFAP), directionally consistent with an XPro treatment effect. These findings support prioritisation of the enriched population in future studies to optimise detection of treatment effects.

David Moss, CEO, INmune Bio, said, “The publication of the phase 2 results from MINDFuL in NPJ Dementia, together with the FDA Fast Track designation, strengthens the value of the XPro platform. The trial also supports a biomarker-enriched (inflammation-enriched) strategy designed to improve future trial design and enhance the potential for clinical success, while reinforcing the broader potential of selective sTNF neutralisation across inflammation-driven diseases.”