INmune Bio Receives EMA’s Authorization in France and Spain for Phase II Clinical Trial of XPro™ for Early Alzheimer’s Disease
27 November 2023 - 2:00PM
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, announced
today it has received European Medicines Agency’s (EMA) Authorized
Decision from the Agence Nationale de Securite du Medicament
et des Produits de Sante (ANSM) in France and the Agencia Espanola
de Medicamentos y Productos Sanitarios (AEMPS) in Spain to initiate
a Phase II trial in Early Alzheimer’s Disease (AD) with
XPro™.
This authorization follows the acceptance of the Company’s
Clinical Trial Application (CTA) under EU Clinical Trials
Regulation and prior EMA's Authorized Decision in
Poland on Nov 15, 2023. The Spanish and French arms are
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 French and Spanish clinical sites will significantly
broaden the trial in Europe. We are grateful for the
collaboration from the ANSM and the AEMPS and look forward to
continuing our progress toward completing enrollment of the Phase
II trial. We believe clinical sites in these two countries
will be significant contributors to the Phase II program and will
be part of the global Phase III clinical trial,” said RJ Tesi M.D.,
CEO of INmune Bio.
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.
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@inmunebio.com
Investor Contact:
Jason NelsonCore IR(516) 842-9614 x-823
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