Data Presentation on XPro1595 for Alzheimer Disease With Inflammation at CTAD

INmune Bio shared positive new neuroimaging data from phase 2 MINDFuL trial of Xpro1595 for patients with early Alzheimer disease and neuroinflammation.¹ The study results are being presented at the Clinical Trials on Alzheimer’s Disease conference, occurring December 1-4 in San Diego, California.

"These PerpDP+ data represent one of the clearest signals yet that selectively neutralizing soluble TNF can interrupt the neurodegenerative cascade at its microstructural root in AD driven by inflammation," said CJ Barnum, PhD, head of neuroscience at INmune Bio, in a press release. "We are excited to analyze the remaining imaging data and to report on this at subsequent meetings and in publications," he added.

The MINDFuL trial was a randomized, double-blind, placebo-controlled study of patients with early Alzheimer disease and elevated inflammatory markers. Patients randomly received either XPro1595 or placebo. The study used PerpPD+, a magnetic resonance imaging (MRI) analysis that quantifies diffusion components of water molecules perpendicular to cortical gray matter microcolumns. Analysis focused on participants with early Alzheimer disease and high inflammatory burden, including a dose-compliant subgroup. Analysis highlighted change from baseline to 24 weeks in PerpPD+ measurements.

Steven Chance, chief executive officer of Oxford Brain Diagnostics, noted in a press release that"XPro1595 is one of the pioneering interventions to examine the powerful role the innate immune system plays in Alzheimer's disease pathology. Quantitative and precise biomarkers like cortical disarray measurement was one of the secondary outcome measures in INmune Bio's phase 2 Alzheimer's study. In the dose compliant participants, CDM showed a trend for reduced cortical disarray, indicating lower neurodegeneration."

Data showed XPro1595 slowed disease progression, as seen from a trend of attenuated increase in PerpPD+. This slowed increase is thought to indicate microscopic disruption of disarray in the cortical structure. With lessened structural issues, this reduction may show a slowing of neurodegeneration. INmune Bio also noted that these neuroimaging results are in line with previously reported directional effects on biological, cognitive, and neuropsychiatric endpoints. Previous studies on this medication included the 2019 phase 1b trial for safety, a 2021 treatment of 6 patients with Alzheimer disease, and the phase 2 trials beginning in 2022. A prior phase 2 MINDFuL study in June 2025 had showed a missed primary endpoint.

XPro1595 is a recombinant protein variant of human tumor necrosis factor designed to selectively neutralize the soluble, proinflammatory form of the cytokine.² The drug neutralizes the pathological soluble tumor necrosis factor and preserve neuroprotective transmembrane tumor necrosis factor signaling. This function is a mechanistically distinct approach from many other amyloid-targeting therapies.³

References

1. INmune Bio reports new phase 2 grey matter imaging data at CTAD conference reinforcing XPro1595’s evidence base in high-inflammation Alzheimer’s patients. Press release. December 1, 2025. Accessed December 3, 2025. https://www.benzinga.com/pressreleases/25/12/g49133452/inmune-bio-reports-new-phase-2-grey-matter-imaging-data-at-ctad-conference-reinforcing-xpro1595s-e

2. A study of XPro1595 in patients with early Alzheimer’s disease with biomarkers of inflammation (MINDFuL). ClinicalTrials.gov. August 17, 2025. Accessed December 3, 2025. https://clinicaltrials.gov/study/NCT05318976

3. Jaeger J, Staats KA, Barnum S, et al. XPro1595, a selective soluble TNF neutralizer, in early Alzheimer’s disease with inflammation (ADi): results from the phase 2 MINDFuL trial. 2025.