Full Press Release Details
INmune Bio Inc. Presents Baseline Demographics
and Disease Profiles of Participants in the MINDFuL Phase II Study
MINDFuL Phase II Blinded,
Randomized, Placebo-Controlled Data Anticipated June 2025
Boca Raton, Florida, April 01, 2025 (GLOBE
Bio, Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage inflammation and immunology company focused on developing
treatments that harness the patient's innate immune system to fight disease, is presenting a poster at the annual International
Conference on Alzheimer's and Parkinson's Diseases and Related Neurologic Disorders taking place in Vienna, Austria April
1-5 2025. AD/PD is the largest Alzheimer's conference in Europe. The poster details the demographics and biomarker status
of patients at the time of enrollment in the MINDFul Phase II blinded, randomized trial in patients with early AD and biomarkers of inflammation.
Patients enrolled in the MINDfuL trial (N=208)
were diagnosed with either MCI (n=92, 44%) or mild AD (mAD, n=116, 56%). The average age was 72 years across both diagnostic categories.
All enrolled patients met enrichment criteria for at least one of the following biomarkers of inflammation: hsCRP > 1.5 mg/L; ESR >
10 mm/hr; HbA1c > 6.0 %; or at least one APOE 4 allele. Patients were randomized 2:1 to receive either XPro 1.0
mg/kg or placebo by subcutaneous injection given once per week for 23 weeks.
The primary endpoint in the MINDFuL trial
is change from baseline in cognitive scores measured with the Early and Mild Alzheimer's Cognitive Composite (EMACC). As reported
elsewhere, the EMACC was designed specifically to serve as an objective outcome measure in Early AD clinical trials. The EMACC provides
improved sensitivity for detection and tracking
Baseline scores on the EMACC were higher in
the MCI vs mAD groups and correlated with scores on both the MMSE and CDR-SB, indicating good construct validity for the primary endpoint.
The screen failure rate in the MINDfuL trial
was 72%, with disease severity as measured by screening MMSE as the most common reasons for exclusion.
"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. "69.2% of the patients enrolled
in our trial are APOE 4 carriers and 64.4% met inclusion criteria for more than one enrichment biomarker. Enrichment biomarker
profiles are evenly distributed across both genders and diagnostic categories. Patient age, disease duration and other characteristics
show striking similarity to patients enrolled in much larger and successful Phase III trials in Early AD."
Secondary endpoints in the MINDFuL trial include
the CDR-SB, E-Cog, ADL and Neuropsychiatric Inventory (NPI) instruments, along with blood biomarker and neuroimaging outcomes. Baseline
demographics, disease characteristics and study design details will be presented on April 4-5 during poster session 2 at AD/PD 2025:
Poster #294: ALZHEIMER'S DISEASE (AD)
AND IMMUNE DYSFUNCTION: BASELINE DEMOGRAPHICS AND DISEASE CHARACTERISTICS FROM A PHASE-2 STUDY OF XPRO1595 IN EARLY AD
Topline results of the MINDFuL trial will
be reported in June 2025.
About INmune Bio Inc.
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. DN-TNF product candidates are in clinical trials to determine if they can treat Mild Alzheimer's disease,
Mild Cognitive Impairment and treatment-resistant depression (XPro ). The Natural Killer Cell Priming Platform includes INKmune developed
to prime a patient's NK cells to eliminate minimal residual disease in patients with cancer and is currently in trials in metastatic
castration-resistance prostate cancer. The third 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. INmune Bio's product platforms utilize a precision medicine approach for diseases driven by chronic inflammation and 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 that do not describe historical
facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995.
Any statements contained in this press release that do not describe historical facts 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 a number of risks and uncertainties. Actual results and the timing of certain events and circumstances
may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. CORDStrom ,
XPro1595 (XPro ), and INKmune are still in clinical trials or 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 in order to reflect any event or circumstance that may arise after the
date of this release.
Co-founder and Chief Financial Officer
Head of Investor Relations