- The study shows a strong correlation between SARS-CoV-2
infection, W-ENV protein and markers of innate immunity, in
patients with psychiatric disorders
- The results confirm the interest of treating post-COVID
neuropsychiatric syndromes by neutralizing the W-ENV protein with
the temelimab antibody
- GeNeuro is preparing to launch a phase 2 clinical trial in 200
patients with post-COVID syndromes and positive for W-ENV
Regulatory News:
GeNeuro (Euronext Paris: CH0308403085 - GNRO), a
biopharmaceutical company developing new treatments for
neurodegenerative and autoimmune diseases, such as multiple
sclerosis (MS), amyotrophic lateral sclerosis (ALS) and the severe
neuropsychiatric consequences of COVID-19 (post-COVID), and the
FondaMental Foundation, a scientific cooperation foundation serving
patients with mental illness, presented at the Schizophrenia
International Research Society (SIRS) congress from April 6 to 10
in Florence, Italy, the first data resulting from their
collaboration launched in 2021, in the context of COVID.
These results were presented during the session entitled
"Human Endogenous Retrovirus (HERV) as a Missing Link between
Inflammation and Schizophrenia in the Context of COVID" with
presentations by Prof. Marion Leboyer (Université
Paris-Est-Créteil, Hôpital H. Mondor, FondaMental Fondation,
Créteil, France), Dr. Livia de Picker (University of Antwerp,
Belgium), Prof. Urs Meyer (University of Zurich, Switzerland) and
Dr. Hervé Perron (GeNeuro), and concluded by Prof. Robert Yolken
(Johns Hopkins University, Baltimore, USA).
The first results presented in Florence were based on the
analysis of blood samples from 104 patients hospitalized between
January and March 2021 for psychiatric disorders, either for the
first time or because of relapses, in the psychiatry department of
Prof. Leboyer in Créteil at Hôpital H. Mondor, and 63 controls.
The objective of this analysis was to measure the coronavirus
infection rate in a population with no reported COVID disease and
to search for links between SARS-CoV-2 infection and the endogenous
retroviral protein W-ENV. The analyses were performed by the INSERM
"We-Met" platform at the Paul Sabatier University in Toulouse.
SARS-CoV-2 specific serological analyses showed that 82% of the
patients admitted to the psychiatric ward had been exposed to the
COVID-19 virus. The detection of W-ENV protein was positive in the
serum of 40% of the patients studied, but almost exclusively and
very significantly in patients seropositive for SARS-CoV-2
(p<0.01). The presence of W-ENV protein in the blood was also
strongly correlated with elevated levels of cytokines
characteristic of innate inflammation such as TNF-α, IL-1β or IL8
(p<0.0001 for all three).
"We have repeatedly, in independent cohorts, shown the presence
of W-ENV protein in blood samples of patients with psychotic
spectrum disorders and chronic systemic inflammation," said
Prof. Marion Leboyer, Director of the Department of Psychiatry at
Henri Mondor University Hospitals (Université Paris Est Créteil)
and Director of the FondaMental Foundation. "The results of our
study in these patients hospitalized during the COVID-19 pandemic
revealed that most of them had been exposed to SARS-CoV-2. These
data reinforce the interest of a personalized therapeutic approach
in W-ENV positive patients against neuropsychiatric syndromes in
the post-COVID-19 context."
Studies published in 2021 had shown that W-ENV expression was
triggered by SARS-CoV-2 in the white blood cells and tissues of
about 20% of healthy donors, suggesting individual susceptibility.
This protein was also detected in the blood of hospitalized
COVID-19 patients where the amount of expression in lymphocytes was
associated with disease progression severity. The persistence of
W-ENV expression long after the acute phase of the disease and its
association with immunoinflammatory manifestations support the
biological hypothesis of its importance in the long-term
neuropsychiatric syndromes suffered by many post-COVID
patients.
"The action of the W-ENV protein on innate inflammation and its
deleterious action on cells of the nervous system have been
documented over the last 20 years," add Dr. Hervé Perron, Chief
Scientific Officer of GeNeuro. "Post-COVID is characterized by
a wide range of symptoms, with probably a multifactorial origin.
But the ability to detect W-ENV in post-COVID patients with
neuropsychiatric disorders allows to identify a well-defined group
of patients that we can rapidly treat with the aim of improving
their condition by neutralizing this pathogenic protein.
GeNeuro has developed temelimab, a specific antibody against the
W-ENV protein, which has shown promising results in Phase II trials
in multiple sclerosis against MRI markers of neurodegeneration.
Temelimab has shown excellent safety and tolerability in several
hundred patients treated for 2 years or more. GeNeuro is preparing
to launch a clinical trial in 200 W-ENV positive patients with
post-COVID neuropsychiatric syndromes. This clinical trial is
co-financed by the Swiss Federal Office of Public Health.
About GeNeuro
GeNeuro's mission is to develop safe and effective treatments
for neurological disorders and autoimmune diseases, such as
multiple sclerosis, by neutralizing the causative factors encoded
by HERVs, which represent 8% of human DNA.
GeNeuro is headquartered in Geneva, Switzerland, and has R&D
facilities in Lyon, France. It has rights to 17 patent families
protecting its technology.
For more information, please visit: www.geneuro.com
About the FondaMental Foundation
The FondaMental Foundation is a scientific cooperation
foundation, located at the Albert Chenevier Hospital, Créteil
(France). Its mission is to innovate in the organization of care,
to support research and innovation in the service of mental
illnesses, to deploy training and to improve information to reduce
stigma.
For more information, please visit:
www.fondation-fondamental.org
Disclaimer This press release contains certain
forward-looking statements and estimates about GeNeuro's future
financial condition, results of operations, strategy, plans and
performance and the markets in which it operates. These
forward-looking statements and estimates can be identified by words
such as "anticipate," "believe," "may," "estimate," "expect,"
"intend," "is designed to," "may," "could," "plan," "potential,"
"predict," "objective," "should," or the negative of these terms
and other similar expressions. They include all matters that are
not historical facts. Forward-looking statements, forecasts and
estimates are based on management's current assumptions and
assessment of known and unknown risks, uncertainties and other
factors that were believed to be reasonable at the time they were
made but may prove to be incorrect. Events and results are
difficult to predict and depend on factors beyond the Company's
control. Consequently, the actual results, financial condition,
performance and/or achievements of GeNeuro or the industry may
differ materially from future results, performance or achievements
expressed or implied by such statements, forecasts and estimates.
Because of these uncertainties, no representation is made as to the
accuracy or correctness of such forward-looking statements,
forecasts and estimates. Furthermore, forward-looking statements,
forecasts and estimates speak only as of the date they are made,
and GeNeuro undertakes no obligation to update or revise them,
whether as a result of new information, future events or otherwise,
except as required by law.
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Press Contacts :
FondaMental Foundation: Laurence de la Touche / +33 6 09 11 11
32 - laurence@agencethedesk.com
GeNeuro : Arthur Rouillé / +33 (0)1 44 71 00 15 -
arouille@newcap.fr
GeNeuro contacts
GeNeuro Jesús Martin-Garcia President and CEO +41 22 552
4800 investors@geneuro.com
NewCap (France) Mathilde Bohin / Louis-Victor Delouvrier
(investors) +33 1 44 71 98 52 Arthur Rouillé (media) +33 1 44 71 94
98 geneuro@newcap.eu
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