Full Press Release Details
INmune Bio Reports Key Findings from Phase 2 MINDFuL Trial of XPro
in Early Alzheimer's Disease
In the Phase 2 MINDFuL trial of XPro in patients
with early Alzheimer's Disease (AD) with biomarkers of inflammation, the modified intent-to-treat (mITT) population (n=200) did
not meet the primary cognitive endpoint (EMACC), however in a predefined population of amyloid-positive early AD patients with two
or more biomarkers of inflammation (n=100), a benefit of XPro treatment over placebo was observed in cognitive, behavioral
and biological endpoints.
Treatment with XPro was well-tolerated and safe,
even in the high risk ApoE4+/+ patient group, and ARIA-E or ARIA-H was not observed in any patients. The most common adverse events (AE)
were injection site reactions.
Additional analyses will be presented at Alzheimer's Association
International Conference (AAIC) in Toronto, Canada (July 27-31, 2025) and the Company will submit for Breakthrough Therapy designation
Conference call today at 8AM ET, details below.
Boca Raton, June 29, 2025 (GLOBE NEWSWIRE) -- INmune Bio
Inc. (NASDAQ: INMB), today announced results from its Phase 2 MINDFuL trial (NCT05318976) evaluating XPro , a selective soluble
TNF inhibitor, in early AD with biomarkers of inflammation. Despite showing no effects in the modified intent-to-treat population (mITT,
n=200), predefined analyses demonstrated a cognitive benefit for XPro over placebo on the primary endpoint EMACC, a behavioral
benefit on the Neuropsychiatric Inventory, and a biological benefit on pTau217 in early Alzheimer's patients with two or more biomarkers
of inflammation at baseline (n=100), marking a key milestone in the development of XPro for Early AD.
The MINDFuL trial, a double-blind,
placebo-controlled study, enrolled 208 participants with early-stage AD to assess XPro 's potential in slowing cognitive
decline by tackling neuroinflammation. Patients with at least one of four inflammatory biomarkers (elevated CRP, ESR, HbA1c, or at
least one ApoE4 allele) were randomized 2:1 (XPro :placebo) and treated over 24 weeks. The primary endpoint was change in
cognition over 6 months on the Early Mild Alzheimer's Cognitive Composite (EMACC), a cognitive assessment designed
specifically to measure change in early AD patients. While the primary endpoint was not met in the mITT group, key changes in
clinical measures of cognition, behavior, and an AD-related biomarker demonstrated a benefit in a subpopulation of patients treated
with XPro over patients treated with placebo. These results identify a clear population of AD patients for which XPro
might have therapeutic benefit.
Key Findings in the Amyloid positive Early AD participants with
two or more biomarkers of inflammation (N=100):
"These results highlight the potential
of XPro ," stated RJ Tesi, MD, CEO of INmune Bio. "Our findings indicate that XPro may offer benefits to
Alzheimer's patients across all age groups, regardless of comorbidities, additional medications, or ApoE4 status. This
evidence lays the foundation for advancing XPro as a promising treatment option for Alzheimer's disease."
CJ Barnum, PhD, VP of CNS Drug
Development, added, "By targeting neuroinflammation, a key driver of Alzheimer's disease progression, XPro offers
a novel mechanism to potentially slow disease progression and cognitive symptoms for persons living with Alzheimer's disease and
inflammation. The continued development of this therapeutic, whether as a standalone treatment or in combination with other therapies,
holds promise in addressing this critical and growing unmet medical need."
Additional analyses are underway and will be presented at AAIC in Toronto,
Canada (July 27-31, 2025).
Expert Commentary on Use of Effect Size in Clinical Trials
"In early-phase Alzheimer's disease trials, absolute effect
sizes of 0.2 or greater are considered preliminary evidence of potential therapeutic efficacy and are informative for signal detection
in early phase studies when sample sizes are small and the unknowns of a novel mechanism are significant," said Dr. Judith Jaeger,
a leading expert in cognitive assessment and consultant to INmune Bio on this trial. "When a therapy consistently meets the 0.2
benchmark across multiple parameters (clinical and biological), confidence in the validity of the observed effects increases, indicating
a therapy is worth advancing."
INmune Bio will present additional analyses from the MINDFuL trial
at AAIC in Toronto, Canada (July 27-31, 2025). Based on the totality of the data, the company intends to:
MINDFuL Results Call Information:
To participate in this event, dial approximately at least 10 minutes
before the beginning of the call or use the webcast link below. Please ask for the INmune Bio MINDFuL Conference Call when reaching the
Time: 8:00 AM Eastern Time
Participant Dial-in: +1-800-267-6316 Participant Dial-in (international): +1-203-518-9783
Conference ID: INMUNE
NOTE: THIS CONFERENCE ID WILL BE REQUIRED FOR ENTRY
To join by webcast link please click here or copy and past
the link below into your browser:
A transcript will follow approximately 24 hours from the scheduled
call. A replay will also be available through July 30, 2025 by dialing 1-844-512-2921 or 1-412-317-6671 (international) and entering pin
INmune Bio wishes to extend their gratitude to the participants, caregivers,
trial site staff, vendors, and any others who supported the efforts of this proof-of-concept phase 2 clinical trial.
About MINDFuL (NCT05318976)
The MINDFuL trial is an international,
blinded, randomized Phase 2 trial in patients with Early AD with biomarkers of elevated neuroinflammation. Early AD includes
patients with MCI (mild cognitive impairment) and mild AD. Patients must have at least one of four biomarkers of inflammation
- elevated CRP, HgbA1c, ESR or ApoE4 allele. Patients receive either XPro or placebo (2:1 ratio) for 6 months.
The cognitive endpoints are EMACC and CDR. XPro is given as a once-a-week subcutaneous injection. For more information on the
MINDFuL clinical trial please visit www.clinicaltrials.gov or www.inmunebio.com
About Judith Jaeger, PhD
Judith Jaeger, PhD, is the principal developer of the EMACC. Judith
Jaeger PhD is founder and President of CognitionMetrics, a prominent neurocognition consulting firm. Dr. Jaeger is an internationally
recognized expert in designing cognitive function testing programs to use in clinical trials with more than two decades' experience.
The EMACC is a validated cognitive composite derived from six standardized
neuropsychological tests, empirically developed to provide optimal for sensitivity to decline in early AD. Unlike traditional clinical
rating scales, EMACC minimizes variance from informant demographics, providing an objective measure of cognitive performance with no floor
XPro is an advanced tumor necrosis factor (TNF) inhibitor that
targets soluble TNF (sTNF) while preserving trans-membrane TNF (tmTNF) and TNF receptors. By reducing neuroinflammation, XPro may
offer significant benefits for patients with neurologic disorders, potentially enhancing cognitive function and supporting neuronal communication.
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. 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 allogeneic, pooled, 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.
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