INmune Bio Inc. Announces Expansion of Phase II Clinical Trial for Alzheimer’s Disease in Europe
15 Noviembre 2023 - 8:00AM
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 in the
brain.
“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 programs.
"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.
About XPro™
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.
INmune Bio Contact:
David Moss, CFO (858) 964-3720
info@inmunebio.com
Investor Contact:
Jason Nelson Core IR (516) 842-9614 x-823
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