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INmune Bio Inc. Announces Final Enrollment of 208 Patients in Phase 2 Trial in Early Alzheimer's Disease Boca Raton, Florida

Key Takeaway: INmune Bio Inc. announced that it has completed the enrollment of 208 patients in its Phase 2 trial for Early Alzheimer's Disease, known as the AD02 trial. This global trial focuses on patients with neuroinflammation, and the company plans to release top line cognitive results by the second quarter of 2025. The overenrollment in the trial is seen as a major accomplishment, highlighting the commitment of the team and the potential impact of their treatment approach targeting neuroinflammation.

Market Sentiment Analysis

POSITIVE FACTORS

  • Completion of randomization of 208 patients is a significant milestone.
  • The trial is overenrolled, indicating strong interest and potential effectiveness.
  • Potential for advancements in treating Early Alzheimer's disease through novel therapy.

CONCERNS & RISKS

  • Clinical trials are still in early stages, with uncertain outcomes.
  • No assurance of FDA approval or desired outcomes from the trials.

Full Press Release Details

INmune Bio Inc. Announces Final Enrollment
of 208 Patients in Phase 2 Trial in Early Alzheimer's Disease
Boca Raton, Florida, Nov. 13, 2024 (GLOBE NEWSWIRE) -- INmune
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 announced today that it completed randomization of patients
for its Phase 2 trial on Monday, November 11th. This global, blinded, randomized Phase 2 trial (the "AD02 trial") is focused
on patients with Early AD and biomarkers of elevated neuroinflammation.
"We are excited to have completed administering first doses to
all patients enrolled in our phase 2 Alzheimer's trial," stated RJ Tesi PhD, the CEO of INmune Bio. "A global trial
of this size is a major accomplishment for INmune and is a testament to the hard work and dedication of our team. The trial ended up overenrolled
with a total of 208 patients, 56% of whom were categorized as mild AD and 44% as MCI. We look forward to releasing top line cognitive
results in the second quarter of 2025."
AD02 is a global, blinded, randomized Phase II trial in patients with
Early AD using XPro . The trial uses enrichment criteria to focus the trial on patients with neuroinflammation as a cause of their
cognitive decline. XPro targets glial cells that drive neuroinflammation in the brain to allow decreased neurodegeneration and
demyelination with improved synaptic function and remyelination. The primary end-point of AD02 is change from baseline cognitive function
after 24 weeks of therapy, measured using EMACC and CDR-SB.
About Neuroinflammation in AD
Neuroinflammation is chronic inflammation in the brain that is part
of the natural aging process called inflammaging. Neuroinflammation is increased due to behavioral and genetic factors. Neuroinflammation
has been increasingly recognized as a key contributor to the development and progression of neurodegenerative diseases, including Alzheimer's.
Neuroinflammation is a key cause of nerve cell death and synaptic dysfunction that causes cognitive decline. Blocking neuroinflammation
with XPro decreases neurodegeneration and improves synaptic function and promotes remyelination. There are many publications on
the role of neuroinflammation in AD. A recent review can be found here.
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 two product platforms that are both in clinical trials: 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 cancer (INB03 ), 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. INmune Bio's
product platforms utilize a precision medicine approach for the treatment of a wide variety of hematologic and solid tumor malignancies,
and chronic inflammation. 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. INB03 , 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
Managing Director - LifeSci Advisors

Frequently Asked Questions

What is the focus of INmune Bio's Phase 2 trial?

The trial focuses on patients with Early Alzheimer's Disease and neuroinflammation.

How many patients were enrolled in the AD02 trial?

The trial enrolled a total of 208 patients with varying degrees of Alzheimer's.

What is the primary endpoint of the AD02 trial?

The primary endpoint is the change in cognitive function after 24 weeks of therapy.

What role does neuroinflammation play in Alzheimer's?

Neuroinflammation contributes to nerve cell death and cognitive decline in Alzheimer's.

When will the trial results be released?

Top-line cognitive results are expected to be released in the second quarter of 2025.

Last updated: Nov 13, 2024