Full Press Release Details
Inc. Announces Approval of Clinical Trial Application by the U.K. Medicines and Healthcare Products Regulatory Agency for Phase 2 Clinical
Trial in Alzheimer's Disease
The authorization provides
approval for the Company to expand the ongoing Phase 2 trial of XPro in patients with early
Alzheimer's disease to the U.K.
Boca Raton, Florida, Sept. 05, 2023 (GLOBE
NEWSWIRE) -- INmune Bio, Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology company
focused on developing treatments that harness the patient's innate immune system to fight disease, today received authorization
of its Clinical Trial Application (CTA) by the Medicines and Healthcare products Regulatory Agency (MHRA) to initiate a Phase 2 trial
in Early Alzheimer's disease (AD) with XPro . The U.K. CTA is part of the Company's international clinical development
strategy for XPro in patients with early AD. The trial is also enrolling patients in Australia and Canada.
The AD02 Phase 2 clinical trial is a global,
multi-center, randomized clinical study in patients diagnosed with early Alzheimer's disease. In a prior Phase I open-lab trial, INmune
Bio met all primary and secondary endpoints. AD patients treated with XPro exhibited significant reductions in neuroinflammation,
improved axonal integrity, and improved synaptic function. Using sophisticated MRI imaging techniques that allow a "virtual biopsy"
of the brain, treatment of XPro demonstrated improvements in the structural integrity of both gray and white matter in the brain.
"We believe that the United Kingdom serves
as an optimal setting for conducting clinical studies on Alzheimer's disease. The medical community in the region is highly sophisticated,
and patients, along with their dedicated caregivers, exhibit strong motivation to Alzheimer's trials. Moreover, the government recognizes
that Alzheimer's represents not only a medical challenge but also an economic concern," remarked Dr. RJ Tesi, CEO of INmune
Bio. "We firmly believe that establishing clinical study sites for AD02 in the UK will accelerate patient enrollment in this vital
clinical trial, offering novel treatment options to individuals grappling with this debilitating condition."
The UK has one of the highest rates of AD
in the western world (47 cases per 100,000 patients) with almost one million patients diagnosed
with dementia. In 2021, the estimated cost of dementia care in the UK was 25 billion. Dementia is expected to be the costliest
health condition by 2030 and the UK is not in a unique situation. Globally, the number of people living with dementia
is projected to triple by 2050. As a result of the quality of its medical research and the presence of the National Health Service, the
UK plays an important role in advancing therapies for AD.
XPro (XPro1595, pegipanermin) is a
next-generation selective inhibitor of tumor necrosis factor (TNF) that is currently in clinical trials 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 potentially have substantial beneficial effects in patients with neurologic disease by decreasing neuroinflammation, decreasing
neurodegeneration while improving synaptic function and promoting remyelination. 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
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 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 ),
Early Alzheimer's disease, 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.
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