INmune Bio, BOCA RATON, Fla., July 9, 2026
INmune Bio Inc. announced positive new imaging findings from its Phase 2 clinical trial evaluating XPro1595™ (XPro) in patients with early Alzheimer’s disease (AD), demonstrating statistically significant improvements in advanced MRI biomarkers that support the therapy’s biological activity. The data will be presented at the Alzheimer’s Association International Conference (AAIC) 2026, where researchers will showcase evidence of early treatment-related changes in both white matter myelin integrity and cortical microstructure after 24 weeks of treatment.
The study reported a statistically significant treatment difference (p < 0.01) in white matter myelin integrity within the modified intent-to-treat population, with even stronger effects observed among patients selected using the company’s biomarker enrichment strategy. These findings build upon previously announced topline imaging results and provide additional evidence that selective soluble tumor necrosis factor (sTNF) inhibition may positively influence disease-related brain changes before conventional structural imaging methods can detect meaningful differences.
Independent MRI Techniques Confirm Early Biological Activity of XPro
The upcoming AAIC presentation will feature expanded analyses from the MINDFuL Phase 2 study, including complete chi-separation imaging assessing white matter myelin integrity alongside Cortical Disarray Measurement (CDM), an advanced diffusion MRI technique evaluating gray matter microstructure. Importantly, the two imaging technologies rely on different MRI acquisition methods, processing pipelines, and biological measurements, providing independent confirmation of treatment-related effects across distinct regions of the brain. Researchers reported that both imaging endpoints demonstrated concordant improvements following treatment with XPro, strengthening confidence that the observed changes reflect genuine biological effects rather than imaging variability.
According to Dr. CJ Barnum, Vice President of Neuroscience at INmune Bio, preservation of gray and white matter microstructural integrity represents an important biomarker for Alzheimer’s disease because these early pathological changes are closely linked to cognitive decline. Detecting measurable improvements within only 24 weeks suggests that XPro may engage disease biology earlier than traditional volumetric MRI approaches.
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Selective Soluble TNF Inhibition Continues to Show Promise in Alzheimer’s Disease
The company emphasized that myelin preservation has consistently emerged as one of the strongest findings across both preclinical and clinical studies evaluating XPro. Chief Executive Officer David Moss stated that demonstrating treatment-related effects on myelin using highly sensitive imaging technologies reinforces confidence in the drug’s mechanism of action and confirms successful engagement of its intended biological target.
XPro1595™ is designed to selectively neutralize soluble TNF (sTNF), a key driver of chronic neuroinflammation, while preserving the beneficial immune functions associated with transmembrane TNF, providing a differentiated approach compared with broader anti-TNF therapies. By reducing pathological inflammation without suppressing protective immune responses, the therapy aims to slow or modify disease progression in neurodegenerative disorders such as Alzheimer’s disease. The expanded imaging analyses, including longitudinal assessments, subgroup evaluations, and mechanistic insights into white and gray matter changes, will be presented during the “Developing Topics: Biomarkers” poster session at AAIC 2026, taking place July 12–15, 2026, in London, United Kingdom..
XPro Advances Toward Registrational Development in Neuroinflammation
The latest imaging data further strengthen the clinical development program for XPro1595™, which recently received FDA Fast Track Designation and regulatory alignment following an End-of-Phase 2 meeting with the agency. INmune Bio is preparing an integrated Phase 2b/3 seamless adaptive registrational trial focused on patients with neuroinflammation-enriched early Alzheimer’s disease, utilizing its precision medicine strategy to identify individuals most likely to benefit from therapy.
The company’s development approach combines advanced biomarker selection with targeted modulation of the innate immune system to improve clinical outcomes. Beyond XPro, INmune Bio is also advancing CORDStrom™, its allogeneic mesenchymal stromal cell platform, toward regulatory submissions in both Europe and the United States. The positive Phase 2 imaging findings provide additional evidence supporting XPro1595™ as a promising investigational therapy capable of targeting early disease mechanisms in Alzheimer’s disease, reinforcing its potential to become an important precision medicine treatment for patients with neuroinflammatory-driven cognitive decline.
Source: INmune Bio press release
