INmune Bio Announces Submission of Phase 2 MINDFuL Trial Results in Alzheimer’s Disease to npj Dementia, a Nature Portfolio Journal

Rhea-AI Summary

INmune Bio (NASDAQ: INMB) has submitted results from its Phase 2 MINDFuL trial of XPro™ in Alzheimer's disease to npj Dementia journal. While the trial did not meet its primary endpoint in the overall population, it showed promising results in a specific subgroup of patients with both amyloid pathology and high inflammatory burden (ADi population).

Key findings in the ADi population demonstrated positive trends across cognitive, neuropsychiatric, and biological endpoints. Notably, XPro™ showed a complete absence of amyloid-related imaging abnormalities (ARIA), a common side effect in other Alzheimer's treatments, even in high-risk patients including APOE4 carriers. The company expects FDA regulatory feedback in Q1 2026.

Positive

• Promising efficacy signals in ADi subgroup population
• Complete absence of ARIA side effects, even in high-risk patients
• Strong safety profile supporting potential broader use and combination therapies
• Positive trends across multiple endpoints in biomarker-enriched population

Negative

• Failed to meet primary endpoint in overall trial population
• Benefits limited to specific subgroup of patients
• Regulatory approval pathway uncertain pending FDA feedback

Insights

Neuroscience Clinical Trial Specialist

INmune Bio's Phase 2 trial missed primary endpoint but showed promise in inflammatory Alzheimer's subgroup with excellent safety profile.

INmune Bio's submission of their Phase 2 MINDFuL trial results to npj Dementia represents a mixed outcome for their Alzheimer's disease candidate XPro™. While the trial did not meet its primary endpoint in the overall study population—a critical metric for any clinical trial—the company highlights promising signals in a prespecified patient subgroup with both amyloid pathology and high inflammatory burden (the ADi population).

The most significant finding is the complete absence of amyloid-related imaging abnormalities (ARIA) across the trial. This safety advantage cannot be overstated, as ARIA represents a serious limitation for the currently approved amyloid-targeting therapies like lecanemab and donanemab, requiring extensive monitoring protocols and restricting patient eligibility. XPro™'s clean safety profile, even in high-risk populations (APOE4 carriers, patients on anticoagulants, and those with cerebral microbleeds), potentially positions it as both a standalone and combination therapy option.

Regarding efficacy, the subgroup analysis showing consistent positive trends across cognitive, neuropsychiatric, and biological endpoints in the ADi population suggests a potential precision medicine approach. However, investors should note that subgroup analyses are inherently less statistically robust than primary endpoint achievements and require confirmation in appropriately powered studies.

The company's planned regulatory discussions in Q1 2026 will be crucial in determining whether the FDA and other agencies will accept this subgroup data as sufficient for pathway to approval or require additional studies specifically targeting the ADi population. This represents a pivotal inflection point that will significantly impact the company's development timeline and capital requirements.

Boca Raton, FL, Sept. 29, 2025 (GLOBE NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB), a clinical-stage inflammation and immunology company, today announces the submission of a manuscript detailing the results of its Phase 2 MINDFuL trial. The manuscript, titled, “XPro1595, a Selective Soluble TNF Neutralizer, in Early Alzheimer’s Disease with Inflammation (ADi): Results from the Phase 2 MINDFuL Trial,” has been submitted for peer review to npj Dementia, a Nature Portfolio journal.

The detailed manuscript provides a comprehensive analysis of the trial, which evaluated the safety and efficacy of XPro™ in patients with early Alzheimer's disease and biological signs of inflammation. While the study did not meet its primary endpoint in the overall population, the findings reveal a promising signal in a prespecified subgroup of patients with both amyloid pathology and a high inflammatory burden, defined by two or more biomarkers of inflammation, referred to as the ADi population. A pre-print of the article can be found by clicking here or following this link: https://www.medrxiv.org/content/10.1101/2025.09.24.25336496v1

"The publication of the MINDFuL trial results with the scientific community highlight the potential therapeutic value of our XPro platform. We are encouraged by the trial results of the subgroup analysis, in addition to the demonstrated strong safety profile, which we believe favorably positions XPro™ for clinical trial advancement,” said CJ Barnum, VP of Neuroscience at INmune Bio.

Key findings within the biomarker-enriched ADi population include:

• XPro™ demonstrated consistent positive trends across cognitive, neuropsychiatric, and biological endpoints, which suggests that targeting neuroinflammation by selectively neutralizing soluble TNF may offer benefits for a specific subset of individuals living with Alzheimer's disease, supporting continued development of XPro™ as a precision medicine approach for this patient group
• Complete absence of amyloid-related imaging abnormalities (ARIA), a serious side effect commonly associated with amyloid-targeting therapies. This favorable safety profile was observed in a high-risk patient population, including significant numbers of APOE4 carriers, patients receiving anticoagulant medications, and individuals with multiple cerebral microbleeds. This distinguishes XPro™ from other treatments and suggests its potential for broader use, including in combination therapies

“Data in the subgroup analysis strongly suggests XPro™ will benefit the trial’s target patient population while also providing a strong rationale for our upcoming end-of-Phase 2 discussions with regulatory authorities, including the FDA, EMA, and MHRA,” stated David Moss, CEO of INmune Bio. “We anticipate receiving regulatory feedback from the FDA in the first quarter of 2026."

For more information about the Phase 2 Alzheimer’s MINDFuL trial or to access the preprint, visit medRxiv.org.

About XPro™

XPro™ (also referred to as “XPro1595”) is a next-generation inhibitor of tumor necrosis factor (TNF) that is currently in clinical trial and acts differently than currently available TNF inhibitors in that it neutralizes soluble TNF (sTNF), without affecting trans-membrane TNF (tmTNF) or TNF receptors. XPro™ could have potential substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation. For more information about the importance of targeting neuroinflammation in the brain to improve cognitive function and restore neuronal communication visit this section of the INmune Bio’s website.

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 system to fight disease. INmune Bio has three product platforms: the Dominant-Negative Tumor Necrosis Factor (DN-TNF) product platform utilizes dominant-negative technology to selectively neutralize soluble TNF, a key driver of innate immune dysfunction and a mechanistic driver of many diseases. The second program, CORDStrom™, is a proprietary pooled, allogeneic, human umbilical cord-derived mesenchymal Stromal/Stem cell (hucMSCs) platform that recently completed a blinded randomized trial in recessive dystrophic epidermolysis bullosa. The third program, INKmune®, is designed to prime a patient’s natural killer cells to eliminate minimal residual disease in patients with cancer and is currently in a trial in metastatic castration-resistance prostate cancer. To learn more, 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 diseases, 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 Contact:
David Moss
Chief Executive Officer
(858) 964-3720
info@inmunebio.com

Daniel Carlson
Head of Investor Relations
(415) 509-4590
dcarlson@inmunebio.com

FAQ

What were the main results of INmune Bio's (INMB) Phase 2 MINDFuL trial in Alzheimer's?

While the trial missed its primary endpoint in the overall population, it showed promising results in the ADi subgroup (patients with amyloid pathology and high inflammatory burden) with positive trends across cognitive, neuropsychiatric, and biological endpoints.

How does INmune Bio's XPro safety profile compare to other Alzheimer's treatments?

XPro demonstrated a superior safety profile with complete absence of ARIA (amyloid-related imaging abnormalities), a serious side effect common in other treatments, even in high-risk patients including APOE4 carriers.

When will INmune Bio (INMB) receive FDA feedback on their Alzheimer's drug?

INmune Bio expects to receive FDA regulatory feedback in the first quarter of 2026.

What makes INmune Bio's XPro different from other Alzheimer's treatments?

XPro is a selective soluble TNF neutralizer targeting neuroinflammation, with a unique safety profile showing no ARIA side effects, potentially allowing for broader use and combination therapies.

Which patient population showed the best results in INmune Bio's MINDFuL trial?

The best results were seen in the ADi population, defined as patients with both amyloid pathology and high inflammatory burden (two or more biomarkers of inflammation).