INmune Bio, Inc. (NASDAQ: INMB) presented detailed baseline demographics and biomarker profiles from its ongoing MINDFuL Phase II clinical trial at the International Conference on Alzheimer's and Parkinson's Diseases (AD/PD) in Vienna, Austria. The data reveals a well-characterized cohort of early Alzheimer's disease patients with confirmed inflammatory biomarkers, setting the stage for anticipated topline results in June 2025.
The MINDFuL trial has enrolled 208 patients diagnosed with either Mild Cognitive Impairment (MCI, n=92, 44%) or mild Alzheimer's disease (mAD, n=116, 56%), with an average age of 72 years across both diagnostic categories. The study is evaluating XPro™, a dominant-negative tumor necrosis factor (DN-TNF) inhibitor that selectively neutralizes soluble TNF, a key driver of innate immune dysfunction implicated in Alzheimer's pathology.
Patient Selection and Inflammatory Biomarkers
All enrolled participants met at least one of four inflammatory biomarker criteria: high-sensitivity C-reactive protein (hsCRP) > 1.5 mg/L, erythrocyte sedimentation rate (ESR) > 10 mm/hr, glycated hemoglobin (HbA1c) > 6.0%, or presence of at least one APOE ε4 allele. Notably, 69.2% of enrolled patients are APOE ε4 carriers, and 64.4% met inclusion criteria for multiple inflammatory biomarkers.
"Preliminary analyses of blinded data at baseline show enrollment of a well-characterized cohort of patients with Early AD and biomarker confirmed inflammation indicative of immune system dysfunction," said CJ Barnum, VP of CNS Drug Development at INmune Bio. "Enrichment biomarker profiles are evenly distributed across both genders and diagnostic categories."
The rigorous patient selection process resulted in a 72% screen failure rate, with disease severity as measured by Mini-Mental State Examination (MMSE) being the most common reason for exclusion. This careful selection approach aims to identify patients most likely to benefit from the anti-inflammatory mechanism of XPro™.
Trial Design and Endpoints
Patients were randomized in a 2:1 ratio to receive either XPro™ at 1.0 mg/kg or placebo via subcutaneous injection once weekly for 23 weeks. The primary endpoint is change from baseline in cognitive scores measured with the Early and Mild Alzheimer's Cognitive Composite (EMACC), an assessment tool specifically designed for early AD clinical trials.
Baseline EMACC scores were higher in the MCI group compared to the mild AD group and correlated well with both MMSE and Clinical Dementia Rating-Sum of Boxes (CDR-SB) scores, indicating good construct validity for the primary endpoint measure.
Secondary endpoints include additional cognitive and functional assessments such as CDR-SB, Everyday Cognition (E-Cog), Activities of Daily Living (ADL), and Neuropsychiatric Inventory (NPI), along with blood biomarkers and neuroimaging outcomes.
Translational Significance
Barnum highlighted that "Patient age, disease duration and other characteristics show striking similarity to patients enrolled in much larger and successful Phase III trials in Early AD," suggesting strong translational potential for the MINDFuL trial results.
This observation is particularly significant given the recent successes of several anti-amyloid therapies in Phase III trials. The MINDFuL trial explores a complementary approach by targeting neuroinflammation, which many researchers believe plays a crucial role in Alzheimer's disease progression.
INmune Bio's Broader Pipeline
Beyond the MINDFuL trial, INmune Bio is advancing a diversified pipeline targeting the innate immune system across multiple disease areas. The company's three technology platforms include:
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The Dominant-Negative Tumor Necrosis Factor (DN-TNF) platform, which includes XPro™ being evaluated not only for Alzheimer's disease but also for Mild Cognitive Impairment and treatment-resistant depression
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The Natural Killer Cell Priming Platform with INKmune®, currently in trials for metastatic castration-resistant prostate cancer
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CORDStrom™, a mesenchymal stem cell platform that recently completed a trial in recessive dystrophic epidermolysis bullosa
The company's approach focuses on precision medicine for conditions driven by chronic inflammation and cancer, with the innate immune system as the central therapeutic target.
The detailed poster presentation (Poster #294: "ALZHEIMER'S DISEASE (AD) AND IMMUNE DYSFUNCTION: BASELINE DEMOGRAPHICS AND DISEASE CHARACTERISTICS FROM A PHASE-2 STUDY OF XPRO1595 IN EARLY AD") will be available during poster session 2 at AD/PD 2025 on April 4-5.
With topline results expected in June 2025, the MINDFuL trial represents a significant milestone in INmune Bio's development of novel treatments for Alzheimer's disease and could potentially provide a new therapeutic option targeting neuroinflammation for patients with early-stage disease.
