INmune Bio Inc. Presents New Biomarker and Feasibility Data from Phase 1b Study Supporting the Use of XPro™ to Treat Alzheimer’s Disease at Clinical Trials on Alzheimer’s Disease (CTAD) Conference
17 Outubro 2023 - 9:00AM
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, highlights some important findings from
data presented at the 16th annual Clinical Trial in
Alzheimer’s Disease (CTAD) to be held October 24-27 in Boston, MA.
INmune is enrolling AD patients into a global, blinded,
randomized Phase II trial. “The Phase Ib trial was designed to
demonstrate that XPro™ reverses neuroinflammation and has been
confirmed by previously presented data,” said CJ Barnum Ph.D.,
VP of CNS Drug Development at INmune Bio. “The trial
further demonstrated many incremental downstream benefits of
reversing neuroinflammation with XPro™. We continue to harvest
information from the extensive data collected from the trial to
improve our understanding of the role of neuroinflammation in AD,
the mechanism-of-action (MOA) of XPro™, and provide insight into
future clinical trial design.”
Summary of CTAD Presentations featuring
XPro:
P186: Feasibility of the Cumulus electrophysiological
neurocognitive platform to enable de-centralized trials in
Alzheimer’s Disease. In a small group of mild to
moderate AD patients, the feasibility of home, self-administered
electroencephalogram (EEG) using the novel system from Cumulus
Neuroscience was tested. The study confirmed the feasibility
of collecting quality EEG signals at home with strong patient
participation and evidence of functional benefit as demonstrated by
an acute and chronic boost in P300 amplitude changes after
treatment with XPro™.
P081: Changes in neurology related CSF proteome after
treatment with XPro1595 for Alzheimer’s
disease. Treatment with XPro™ was associated with
dose-dependent improvement in neurology-related proteins that are
the most strongly associated with the core AD pathologies of
amyloid-beta (Aβ) and phosphorylated tau (pTau), in this sample.
These findings provide further evidence that XPro™ is targeting the
neuronal proteins most affected in AD.
P055: Changes in cortical microstructure in brain
regions associated with cognitive status and disease duration
after short-term treatment with XPro1595 for Alzheimer’s
disease. The poster reports regional improvements in
a diffusion MRI measure of cortical grey matter quality after
short-term treatment with XPro™, in grey matter structures that are
most affected by AD suggesting that XPro™ targets the regions of
the brain most affected by AD.
“Successful drug development requires four key components;
capital, an effective drug, an expert understanding of how the drug
affects the biology of the disease, and strategies to showcase the
clinical benefit of drug therapy in patients. The absence of any of
these critical elements significantly increases the difficulty of
success in a clinical study setting,” said RJ Tesi, M.D., Chief
Executive Officer of INmune Bio. “As seen in our previous studies,
the ability of XPro™ to decrease neuroinflammation results in
wide-ranging benefits, including reducing neurodegeneration and
improving synaptic function, brain microstructure and
remyelination. A goal of our Phase II study in Early AD patients is
to correlate these biologic changes with cognitive function.”
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 the 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
INmune Bio (NASDAQ:INMB)
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