Full Press Release Details
INmune Bio Inc. Announces Expansion of Phase II Clinical Trial for
Alzheimer's Disease in Europe
The Company received regulatory approval to extend its Phase II trial
of XPro in individuals with early Alzheimer's disease in Poland, with additional European Union (EU) countries expected to
The Company received a cash refund of approximately $2.8M USD pursuant
to an Australian Research and Development Tax Incentive.
Boca Raton, Florida, Nov. 15, 2023 (GLOBE NEWSWIRE) -- INmune
Bio, Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology company dedicated to advancing treatments
that leverage the patient's innate immune system to combat disease, has received acceptance of a Clinical Trial Application (CTA)
under EU Clinical Trials Regulation to initiate a Phase II trial in Early Alzheimer's Disease (AD) with XPro in Poland. Additional
regulatory approval for the Phase II AD clinical trial is expected from at least two to potentially six more EU countries in the upcoming
months. The EU approval is part of the Company's international clinical development strategy for XPro in patients with
early AD. The trial is currently enrolling patients in Australia, Canada, and the United Kingdom.
The Phase II clinical trial is a global, multi-center, randomized clinical
study in patients diagnosed with early Alzheimer's disease who have biomarkers of elevated inflammation. In a prior Phase I open-label
trial, INmune Bio met all primary and secondary endpoints. Patients with AD who received XPro demonstrated notable decreases in
neuroinflammation, enhanced axonal integrity, and improved synaptic function. Employing advanced MRI imaging techniques enabling a "virtual
biopsy" of the brain, treatment with XPro demonstrated improvements in the structural integrity of both gray and white matter
"We are delighted with the addition of clinical sites in the
EU. Countries were selected based on their previous experience in Alzheimer's disease research and their interest in novel therapies," said
RJ Tesi M.D., CEO of INmune Bio. "Broadening the clinical presence in the EU serves dual purposes. First, it addresses
the near-term objective of completing enrollment of the Phase II trial. Additionally, the initiation of sites in the EU establishes
the groundwork for realizing our long-term goal of conducting a global Phase III trial."
The Company also recently received a cash refund of approximately $2.8
million pursuant to a research and development tax incentive from Australia. The Company will use the rebate to reinvest in its clinical
"We are delighted with the ongoing receipt of R&D rebates
from research-friendly jurisdictions like Australia. These funds provide a non-dilutive funding source, allowing INmune to reinvest in
expanding recruitment and enrollment not only in Australia and Canada but also in our newer locations in the U.K. and the EU," remarked
David Moss, Chief Financial Officer.
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 Bio's website.
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 ), 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.
David Moss, CFO (858) 964-3720
(516) 842-9614 x-823