INmune Bio to Present Positive Phase 2 Imaging Data for XPro in Early Alzheimer’s Disease at AAIC
Advanced MRI analyses showed early treatment-related changes in white matter myelin integrity and cortical microstructure at Week 24, supporting biologic activity of selective soluble TNF inhibition.
White matter myelin integrity demonstrated a statistically significant treatment difference at Week 24 in the modified intent-to-treat population (p < 0.01), with larger effects observed in patients selected using the company’s biomarker enrichment strategy.
BOCA RATON, Fla., July 09, 2026 (GLOBE NEWSWIRE) -- INmune Bio Inc. (NASDAQ:INMB), a late-stage biotechnology company focused on inflammation and immunology, today announced new imaging data from its Phase 2 study of XPro in patients with early Alzheimer’s disease (AD). The data, to be presented at the Alzheimer’s Association International Conference (AAIC), support early, concordant treatment-related effects across independent white matter and gray matter imaging endpoints.
The presentation, titled "Concordant White Matter and Cortical Treatment Effects in a Phase 2 Study of XPro1595 in Early Alzheimer’s disease," highlights the full chi-separation analysis of white matter myelin, together with cortical disarray measurement (CDM), an advanced diffusion-MRI measure of gray matter microstructure. The two techniques rely on different MRI contrast mechanisms: chi-separation uses magnetic susceptibility, while CDM uses water diffusion. They also use separate acquisition sequences and processing pipelines and, in this study, were applied to different tissue compartments. Because these methodologically independent measures changed in the same direction, their concordance supports the interpretation that the observed changes are treatment-related and reflect effects on brain microstructure.
"Microstructural integrity in gray and white matter represents an important set of biomarkers in Alzheimer’s disease because these changes reflect early pathological processes that contribute to cognitive decline," stated Dr. CJ Barnum, Vice President of Neuroscience at INmune Bio. "Detecting a treatment effect on white matter myelin within just 24 weeks, corroborated by cortical gray matter changes measured using an independent imaging method, supports the conclusion that XPro™ is engaging relevant biology earlier than traditional volumetric approaches would be expected to reveal."
The upcoming AAIC presentation builds directly on the positive topline imaging results reported by INmune Bio on June 2, 2026. The results showed a statistically significant treatment effect on a white matter myelin biomarker in the modified intent-to-treat population at Week 24 (p<0.01), with larger effects observed in patients selected using the company’s biomarker enrichment strategy.
"XPro’s effect on myelination remains one of the most robust and consistent findings across our preclinical and clinical work, giving us real confidence in the drug and in target engagement," said David Moss, Chief Executive Officer of INmune Bio. "Showing an early, treatment-related effect on myelin, the tissue at the center of many neurologic diseases, using imaging sensitive enough to detect it speaks to the broader potential of selective soluble TNF inhibition, and reinforces our confidence in XPro’s potential."
AAIC 2026 Poster Presentation
INmune Bio will present expanded imaging analysis from the MINDFuL study at the Alzheimer's Association International Conference (AAIC) 2026, taking place July 12–15, 2026, in London, United Kingdom, and online. The poster, titled "Concordant White Matter and Cortical Treatment Effects in a Phase 2 Study of XPro1595 in Early Alzheimer's disease" (Abstract Control No. 13497), will be presented in the "Developing Topics: Biomarkers" in-person poster session on Sunday, July 12, 2026, from 7:30 a.m. to 4:15 p.m. local time in the Exhibit Hall. The poster will include longitudinal analyses, subgroup data, and mechanistic context for both the white matter myelin and complementary cortical microstructure imaging endpoints.
About INmune Bio Inc.
INmune Bio Inc. is a publicly traded (NASDAQ:INMB), late-stage biotechnology company focused on developing treatments that target the innate immune system to fight disease. Moving beyond early-stage exploration, the Company’s clinical-development strategy centers on advanced precision medicine, matching drug mechanisms directly to patient biology to optimize clinical outcomes.
INmune Bio is actively advancing two late-stage product platforms toward registrational milestones:
- CORDStrom™: A proprietary, pooled, allogeneic, human umbilical cord-derived mesenchymal stromal cell platform engineered to address the historical clinical challenges of donor variability and manufacturing inconsistency. Following successful clinical readouts in RDEB, the platform is transitioning to regulatory filing phases, with an MAA planned for the UK MHRA and EU EMA in 2026, alongside a planned U.S. Biologics License Application (BLA) submission.
- XPro1595™: A Dominant-Negative Tumor Necrosis Factor (DN-TNF) platform that selectively neutralizes soluble TNF (sTNF) to reduce pathological neuroinflammation without compromising protective immune function. Backed by recently granted FDA Fast Track designation and successful regulatory alignment from an End-of-Phase 2 meeting, XPro1595™ is positioned for an integrated Phase 2b/3 seamless adaptive registrational program in neuroinflammation-enriched early Alzheimer’s disease.
To learn more about INmune Bio’s pipeline and its approach to harnessing the innate immune system, please visit www.inmunebio.com.
Forward Looking Statements
Clinical trials are in early stages and there is no assurance that any specific outcome will be achieved. Any statements contained in this press release related to the development or commercialization of product candidates and other business and financial matters, including without limitation, trial results and data, including trial results, timing of key milestones, future plans or expectations, and the prospects for receiving regulatory approval or commercializing or selling any product or drug candidates, may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any forward-looking statements contained herein are based on current expectations but are subject to several risks and uncertainties. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements because of these risks and uncertainties. CORDStrom™ (ebstrocel for RDEB), XPro1595™ (XPro™, pegipanermin), and INKmune™ have either finished clinical trials, are still in clinical trials or are preparing to start clinical trials and have not been approved by the US Food and Drug Administration (FDA), the UK MHRA or any regulatory body and there cannot be any assurance that they will be approved by the FDA, the UK MHRA or any regulatory body or that any specific results will be achieved. The factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the Company’s ability to produce more drug for clinical trials; the availability of substantial additional funding for the Company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and the Company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies. Imaging and biomarker endpoints may not predict clinical benefit, and subgroup or enrichment analyses may not be replicated in future studies. These and other factors are identified and described in more detail in the Company’s filings with the Securities and Exchange Commission, including the Company’s Annual Report on Form 10-K, the Company’s Quarterly Reports on Form 10-Q and the Company’s Current Reports on Form 8-K. The Company assumes no obligation to update any forward-looking statements to reflect any event or circumstance that may arise after the date of this release.
INmune Bio Contacts:
David Moss
Chief Executive Officer
(561) 710-0512
info@inmunebio.com
Daniel Carlson
Head of Investor Relations
(415) 509-4590
dcarlson@inmunebio.com
