INmune Bio, Inc. (NASDAQ:
INMB) (the “Company”), a clinical-stage immunology company
targeting microglial activation and neuroinflammation as a cause of
Alzheimer’s disease (AD) reports significant improvements in
electroencephalography (EEG), a biomarker of brain function, in
patients with moderate to severe Alzheimer’s Disease treated with
XPro™ for four weeks.
Patients who received weekly XPro™ treatment for four weeks had
a statistically significant increase in Alpha wave frequency and
power (p<0.05). Reduced Alpha power is linked with cognitive
decline and the progression of Alzheimer’s Disease. Alpha waves
represent synchronized brain network activity that are
essential for internal functions like mental arithmetic, short-term
and working memory, and visual-spatial mental imagery exercises.
In individuals with AD, Alpha wave power is diminished due to
the breakdown of brain networks associated with degeneration.
"Functional benefits are the true benchmark of a drugs
biological efficacy, and these promising findings are part of a
larger narrative that's still unfolding,” stated CJ Barnum, PhD, VP
of Neuroscience at INmune Bio. “We are committed to extensive
research, drawing from our Phase 2 placebo-controlled trial to
substantiate these findings.”
The seven patient pilot study in patients with moderate to
severe AD sought to evaluate the utility of EEG as a functional
biomarker of target engagement in evaluating the effects of XPro™
(XPro1595; pegipanermin), a next generation dominant-negative
inhibitor of soluble TNF, in AD patients. These positive results
support and add to the findings of the Phase 1 study in patients
with AD that showed XPro™ treatment reduced biomarkers of
inflammation and improved biomarkers of neurodegeneration, synaptic
function and improved brain microstructure and promoted
remyelination. The extent to which these biomarker changes impact
cognition in patients with Early Alzheimer's Disease is currently
being assessed in our ongoing randomized, placebo-controlled
Phase 2 trial.
EEG, long considered a gold standard in objectively measuring
brain activity, provides valuable insight into neural connectivity.
Neurological research has consistently highlighted a progressive
decline in alpha band power and frequency in individuals with MCI
and Alzheimer's disease. EEG's capability to assess brain function
makes these findings particularly noteworthy for INmune Bio’s novel
treatment strategy. The use of EEG as a biomarker for brain
function and its potential as a regular measure in clinical trials
was facilitated by Cumulus Neuroscience’s innovative, FDA approved,
portable EEG device.
“It is unprecedented to continuously monitor brain function at
this scale. Our goal is to bring reliable, clinic-level brain
function measurement into the comfort and familiarity of a
patient's home,” remarked Brian Murphy, Ph.D., Chief Scientific
Officer of Cumulus Neuroscience. "The work highlights the untapped
potential in utilizing task-synchronized EEG throughout the
drug-development process in patients with Alzheimer’s disease,
which could revolutionize how clinical trials are conducted and
treatments are evaluated."
Echoing this sentiment, Dr. Barnum emphasized, "Our work with
Cumulus Neuroscience is forging new paths in Alzheimer's research,
by empowering us with the ability to observe real-time effects
of XPro™ on brain function directly within patients’ everyday
lives."
About EEG and Alpha Band Power in AD
EEG is the gold standard for measuring brain activity; informing
on how well neurons are connected within the brain. Quantitative
EEG is reported by the frequency and magnitude of the electrical
signal. The frequency of the EEG is categorized by bands that
correspond to distinct brain activities and states whereas the
magnitude measures how active the neurons are within each band.
The alpha band power, defined around the 8 to 12 Hz frequency
band, increases during internal tasks such as mental calculation,
short-term and working memory or visual-spatial mental imagery
exercises (Vaitl et al., 2005; Klimesch, Sauseng and Hanslmayr,
2007; Palva and Palva, 2007; Lutz, Dunne, and Davidson, 2012). It
broadly reflects coordinated network activity in the brain and is
expected to be reduced by the “disconnection” of networks seen in
neurodegeneration.
In the context of natural aging, alpha power magnitude and
frequency has been observed to reduce over the lifespan (Klimesch,
1999; Scally et al., 2018) and positively correlate with individual
level of cognitive performance among a group of people of a similar
age (Clark et al., 2004). In diseased populations, there is broad
evidence connecting a fall in alpha power and frequency to
cognitive decline and disease progression (Babiloni et al., 2020;
Lejko et al., 2020). Reductions in alpha power and frequency are
also associated with traumatic brain injury and have been
observed to increase during recovery (Ianof and Anghinah, 2017;
Conley et al., 2018). Specifically, global reduction in alpha
power and frequencies are observed in MCI (Mild Cognitive
Impairment) patients compared to healthy older adults, and
progressive MCI is characterized by lower resting alpha power and
frequencies compared to stable MCI (Lejko et al., 2020).
Longitudinal studies in AD patients have also reported lower
magnitude and frequency of alpha rhythms after yearly follow-up
(Babiloni et al., 2020, 2024).
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. XPRO, the
first of several DN-TNF products, is in clinical trials to
determine if it can treat patients with Mild Alzheimer’s disease.
Additional therapeutic indications including d treatment-resistant
depression and oncology will be pursued when resources allow. The
Natural Killer Cell Priming Platform includes INKmune™, a therapy
developed to prime a patient’s NK cells to treat patients with
cancer. INKmune uses a precision medicine approach for the
treatment of a wide variety of hematologic and solid tumor
malignancies. The INKmune trial is enrolling patients into a US
Phase I/II trial in men with metastatic castrate resistant prostate
cancer. To learn more, please
visit www.inmunebio.com.
About Cumulus Neuroscience
With a mission to generate the data and insights required to
accelerate diagnosis and management of central nervous system (CNS)
disorders for millions of patients and caregivers around the world,
Cumulus Neuroscience is advancing an AI-based, multi-domain digital
biomarker platform to enable better, faster decision making in
neurology and neuropsychiatry clinical trials and patient care.
Designed for and with ten of the world's leading pharma companies,
the platform enables decentralized trials, and is already making a
difference in the development of therapies for Alzheimer's Disease,
depression, and schizophrenia.
Designed to provide an industry-wide standard for real-world
measurement of disease progression, Cumulus combines patented
technology, in-house expertise and key industry partnerships to
capture substantial amounts of real-world, clinical data repeated
over time, across multiple behavioral and physiological domains in
the patient's home – all with an EEG headset synchronized to a
novel, tablet-based neuro-assessment platform. Together with
machine learning (ML) analytics and the world's largest database of
annotated, longitudinal, neurofunctional data, Cumulus simplifies
and improves the robustness of neuroscience clinical trials to
provide the best and most cost-effective assessment of CNS
treatment outcomes.
The Company is supported by experienced specialized investors,
DDF/SV Health Investors, LifeArc and Future Fund, and a world-class
Scientific and Technical Advisory Board
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, 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@inmunenbio.com
Investor Contact: Jason Nelson, Core IR (516) 842-9614 x-823
Cumulus Neuroscience Contact:
Julie DietelFINN Partners for Cumulus
julie.dietel@finnpartners.com Tel: 978.502.7705
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