INmune Bio Reports New Phase 2 Grey Matter Imaging Data at CTAD Conference Reinforcing XPro1595's Evidence Base in High-Inflammation Alzheimer's Patients
MWN-AI** Summary
INmune Bio, Inc. (NASDAQ: INMB) recently showcased promising neuroimaging data from its Phase 2 MINDFuL trial of XPro1595 at the 18th Clinical Trials on Alzheimer's Disease (CTAD) conference in San Diego. XPro1595 is an innovative therapeutic aimed at combating early Alzheimer's disease, particularly in patients exhibiting elevated neuroinflammation. The new data emphasize the drug's potential to selectively neutralize soluble TNF (sTNF), a key inflammatory mediator implicated in neurodegeneration.
The findings, derived from advanced grey matter imaging using PerpPD+, indicated a trend toward slowed neurodegeneration in early Alzheimer’s patients with high inflammatory burdens. By analyzing participants' cortical structure, researchers observed a reduction in the increases of cortical disarray, a hallmark of neurodegeneration. This reinforcement of XPro1595's biological rationale aligns with earlier reports on improvements across various clinical endpoints, supporting the idea that targeting inflammation in Alzheimer's may address substantial unmet medical needs.
Dr. CJ Barnum, INmune Bio's Head of Neuroscience, noted that these findings represent a significant indication that sTNF neutralization could disrupt the neurodegenerative process early in the disease course. Meanwhile, Dr. Steven Chance from Oxford Brain Diagnostics highlighted that XPro1595 is pioneering in investigating the innate immune system's role in Alzheimer’s pathology.
Further analyses from the MINDFuL trial are underway, with expectations to yield more comprehensive insights into XPro1595’s impact on brain tissue integrity. The ongoing studies may solidify the drug's position as a unique and promising therapeutic option for Alzheimer’s patients experiencing heightened neuroinflammation, a demographic currently lacking effective treatment alternatives. INmune Bio remains optimistic about the evolving data landscape surrounding XPro1595, which positions it as a potential first-in-class disease-modifying therapy for Alzheimer's disease.
MWN-AI** Analysis
INmune Bio, Inc. (NASDAQ: INMB) recently unveiled compelling Phase 2 neuroimaging data for its investigational drug XPro1595 at the CTAD Conference. This data not only reinforces XPro1595’s potential in treating early Alzheimer’s disease (AD) with high neuroinflammation but also presents an attractive investment opportunity for those looking to capitalize on advancements in biotechnology and AD therapeutics.
The results of the MINDFuL trial showed a trend towards slowed neurodegeneration in patients treated with XPro1595, highlighted by the use of advanced PerpPD+ MRI imaging technology that identified reduced cortical disarray. This aligns well with INmune Bio’s strategy of targeting inflammation-driven AD – a major unmet medical need, comprising a significant segment of the Alzheimer’s population.
Given the current landscape of Alzheimer’s therapies, which largely focus on amyloid beta and tau proteins, the novel approach of addressing intrinsic inflammation represents a unique differentiator for INmune Bio. The evidence presented at CTAD positions XPro1595 as a first-in-class disease-modifying therapy, and upcoming analyses promise to enrich our understanding of its efficacy on brain structure integrity.
Market sentiment towards biotech firms engaged in Alzheimer’s research tends to be volatile; however, with positive clinical results, INMB stands to benefit from increased investor interest and potential partnerships. Traders should monitor share price movements closely, as further detailed analyses in 2026 could drive growth. Moreover, as healthcare systems increasingly seek innovative solutions to manage AD, INmune Bio is poised to capture a significant commercial opportunity.
Investors should consider the risks inherent in biotech investments, particularly regarding regulatory approvals and clinical trial outcomes, but given the potential upside, INmune Bio's recent data warrants careful consideration for those looking to diversify their portfolios in the healthcare sector.
**MWN-AI Summary and Analysis is based on asking OpenAI to summarize and analyze this news release.
Boca Raton, FL, Dec. 01, 2025 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB), a clinical-stage biotechnology company developing inflammation and immunology therapies targeting innate immune dysfunction, announces new neuroimaging data from its Phase 2 MINDFuL trial of XPro1595 in patients with early Alzheimer’s disease (AD) and elevated neuroinflammation. The results will be presented at the 18th Clinical Trials on Alzheimer’s Disease conference (CTAD), being held on December 1-4, 2025 in San Diego, CA.
The new analyses add to the growing body of clinical, biomarker, and imaging evidence supporting XPro1595’s mechanism of selectively neutralizing soluble TNF (sTNF). The data further validate the Company’s strategy of targeting inflammation-driven AD, a large, underserved subset representing a significant unmet need and potential commercial opportunity.
New Grey Matter Signals Strengthen Biological Rationale for XPro1595
Using PerpPD+, a next-generation MRI imaging analysis that quantifies the diffusion components of water molecules that are perpendicular to the cortical gray matter’s minicolumns in the brain (PerpDP+, from Oxford Brain Diagnostics), investigators observed a trend towards slowed neurodegeneration progression in patients receiving XPro1595. These analyses focused on participants with early AD and high inflammatory burden (ADi), including the dose-compliant subgroup.
The PerpPD+ findings suggest attenuated increases in cortical disarray , an imaging hallmark associated with neurodegeneration. These results reinforce previously reported directional improvements across biological, cognitive, and neuropsychiatric endpoints and align with XPro1595’s mechanism of reducing innate immune dysfunction.
“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 Dr. CJ Barnum, Head of Neuroscience at INmune Bio. “We are excited to analyze the remaining imaging data and to report on this at subsequent meetings and in publications.”
Dr. Steven Chance, CEO of Oxford Brain Diagnostics added:
“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 (CDM) 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."
Key Highlights
- The poster presentation of XPro1595, a Selective Soluble TNF Neutralizer, in Early Alzheimer’s Disease with Inflammation (ADi): Results from the Phase 2 MINDFuL Trial outlines the first neuroimaging results of the Company’s Phase 2 randomized, double-blind, placebo-controlled study in patients with early Alzheimer’s disease (AD) and elevated inflammatory biomarkers receiving either XPro1595 or placebo. Results in the change from baseline at 24 weeks in PerpPD+, a grey matter imaging analysis developed by Oxford Brain Diagnostics, were analyzed in participants with early AD and a high inflammatory burden (ADi) and in dose-compliant ADi.
- The data show XPro1595 slowed disease progression as observed by a trend in an attenuated increase in PerpPD+, which indicated microscopic disruption of disarray in cortical structure. This reduction may indicate a slowing of neurodegeneration in the target population. In addition, these neuroimaging results are supportive of the previously reported directional effects on biological, cognitive and neuropsychiatric endpoints.
Additional Imaging Analyses Expected in 2026
INmune Bio confirmed that additional MRI analyses from the MINDFuL trial are ongoing and will be presented when available. These forthcoming data are expected to provide a broader picture of XPro1595’s tissue-level impact on both gray- and white-matter integrity in ADi.
The Company believes totality of data generated to date, including the neuroimaging findings, position XPro1595 as a promising first-in-class disease-modifying therapy for the large subset of Alzheimer’s patients with elevated neuroinflammation. This population has limited treatment options, and no currently approved therapy is designed to target innate immune dysfunction.
About XPro™
XPro™ (Xpro1595, pegipanermin) is a next-generation inhibitor of soluble tumor necrosis factor (sTNF) that preserves trans-membrane TNF (tmTNF) and TNF-receptor signaling. By selective neutralizing sTNF, XPro™ aims to restore healthy innate immune function without the immunosuppressive liabilities associated with traditional TNF inhibitors. XPro™ is currently in clinical development for neurological diseases driven by chronic inflammation.
About INmune Bio Inc.
INmune Bio Inc. is a publicly traded (NASDAQ: INMB), clinical-stage biotechnology company focused on developing treatments that target the innate immune dysfunction to fight disease. The Company’s pipeline include:
- CORDStrom™ , an allogeneic mesenchymal stromal cell platform that recently completed a randomized, blinded study in recessive dystrophic epidermolysis bullosa.
- DN-TNF Platform (XPro™/XPro1595), for neuroinflammatory and neurodegenerative conditions.
- INKMune™ , designed to prime natural killer cells (NK) to eliminate minimal residual disease in cancer.
For more information, 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 the results of the Phase 2 MINDFuL trial, the timing of key milestones, future plans or expectations for the treatment of XPro™, 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™, 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) or any regulatory body and there cannot be any assurance that they will be approved by the FDA 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. 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
FAQ**
How does the new neuroimaging data from INmune Bio Inc. (NASDAQ: INMB) support the efficacy of XPro1595 in modifying the progression of Alzheimer’s disease (AD) among patients with high inflammatory burden?
What additional analyses from the MINDFuL trial can investors expect from INmune Bio Inc. (NASDAQ: INMB) in 2026, and how might these contribute to the understanding of XPro1595’s impact on neurodegeneration?
In what ways does the mechanism of XPro1595, as described by INmune Bio Inc. (NASDAQ: INMB), differ from traditional TNF inhibitors, particularly regarding immune response in Alzheimer’s disease treatment?
What are the potential risks outlined for INmune Bio Inc. (NASDAQ: INMB) regarding the commercialization of XPro1595, and how is the company preparing to address these challenges as clinical trials progress?
**MWN-AI FAQ is based on asking OpenAI questions about INmune Bio Inc. (NASDAQ: INMB).
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