INmune Bio 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
05 Septembre 2023 - 2:00PM
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.
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) 964-3720info@inmunenbio.com
Investor Contact:Jason NelsonCore IR(516)
842-9614 Ext: 823
INmune Bio (NASDAQ:INMB)
Graphique Historique de l'Action
De Avr 2024 à Mai 2024
INmune Bio (NASDAQ:INMB)
Graphique Historique de l'Action
De Mai 2023 à Mai 2024