GeNeuro Announces Completion of Recruitment of Its Long-COVID Phase 2 Trial and Confirms Top-Line Results for June 2024
28 Novembre 2023 - 8:00AM
Business Wire
- Over 200 patients randomized in this precision-medicine
study, making it one of the largest randomized, double-blind,
placebo-controlled trials against long-COVID in the world.
- Study evaluates the efficacy and the safety of the treatment
with temelimab on the improvement in fatigue and cognitive
impairment measures.
- The expression of the pathogenic W-ENV protein, which was a
key inclusion criterion to enter this biomarker-based study, is
confirmed in over 1/3 of patients screened.
- W-ENV is suspected to have a major role in the persistence
of inflammation and in the neurological symptoms affecting these
patients.
- Top-line results will be available in June 2024. Clinical
success would open the path for accelerated pathways to make the
drug available to this underserved population.
- While millions of patients are affected by long-COVID,
GeNeuro’s biomarker-based approach allows to identify those for
whom the treatment may be relevant.
Regulatory News:
GeNeuro (Euronext Paris: CH0308403085 - GNRO), a
biopharmaceutical company focused on stopping causal factors
driving the progression of neurodegenerative and autoimmune
diseases such as multiple sclerosis (MS), amyotrophic lateral
sclerosis (ALS) and Post-Acute Sequelae of COVID-19 (PASC,
long-COVID or post-COVID), today announced the completion of the
recruitment of its Phase 2 trial evaluating temelimab against
long-COVID.
The trial “Temelimab as a Disease Modifying Therapy in Patients
With Neuropsychiatric Symptoms in Post-COVID 19 or PASC Syndrome”
is a randomized, placebo-controlled, biomarker-based, Phase 2
clinical trial assessing the effect of the treatment with temelimab
on the clinical course of these symptoms. The trial has recruited
203 patients across 14 clinical centres in Switzerland, Spain and
Italy. All enrolled patients receive 6 intravenous infusions of
temelimab or placebo (1 to 1 randomization) over 24 weeks. The
clinical endpoints will assess the efficacy and the safety of the
treatment with temelimab on the improvement in fatigue and
cognitive impairment measures.
The recruitment of the trial has already demonstrated that the
expression of the pathogenic W-ENV protein, triggered by the
SARS-CoV-2 infection, may continue long after the acute phase has
been resolved. Over one third of the patients presenting long-COVID
syndromes who were screened were positive to the presence of W-ENV
in their blood. W-ENV is suspected to have a major role in the
persistence of inflammation and in the neurological symptoms
affecting these patients, and temelimab is a highly specific
neutralizing anti-W-ENV-antibody. GeNeuro’s precision medicine
approach allows to identify, within the millions of patients
affected by long-COVID, those for whom the treatment may be
relevant.
“Long-COVID is proving to be a major unmet medical need as
patients who are suffering from its impairing syndromes are often
helpless. The patient response to the study as well as their
dedication to participation has been very encouraging,” said
Prof. Idris Guessous, Head of the Division of Primary Care Medicine
at the Geneva University Hospitals and Principal Investigator of
the study. “We hope that this trial targeting the pathogenic
W-ENV protein will result rapidly into a personalized medicine
approach, identifying and treating patients who may benefit from
the therapy.”
“W-ENV has been shown to be pro-inflammatory and pathogenic to
nervous system cells. Its neutralization with temelimab, a highly
specific antibody with an excellent tolerability profile, aims to
improve symptoms of fatigue and cognitive impairment (“brain fog”).
The trial will establish how much this neutralization impacts the
clinical symptoms affecting long-COVID patients and, if substantial
enough, temelimab could become a first disease-modifying therapy in
this underserved new indication,” said Prof. David Leppert,
Chief Medical Officer of GeNeuro. “We are very grateful to the
patients who have agreed to participate in this important study,
and we also thank the teams of the 14 clinical centres for their
great efforts in opening a new road.”
About Temelimab
The development of temelimab (GNbAC1) is the result of more than
25 years of research into human endogenous retroviruses (HERVs),
including 15 years within Institut Mérieux and INSERM before
GeNeuro was founded in 2006. HERVs have been incorporated into the
human genome during the evolution of mankind and typically remain
“silent genes”, but may be activated under certain conditions and
were found to be involved in the development of auto-immune
diseases. The viral envelope protein encoded by the HERV-W family
(W-ENV) has been found to be pro-inflammatory and pathogenic to
nervous system cells. W-ENV is found in the brains of MS patients,
and particularly in active lesions. In two Phase II multiple
sclerosis trials Temelimab has shown promising results on MRI
features and liquid biomarkers related to neurodegenerative
processes such as brain atrophy.
Temelimab is a neutralizing anti-W-ENV-antibody; by this
capacity it simultaneously blocks inflammatory and
neurodegenerative processes. Given that W-ENV has no known
physiological function, temelimab has demonstrated a good safety
and tolerability profile in the current study, with no effect on
the patient’s immune system, which bears out the profile observed
in all clinical trials carried out to date.
About GeNeuro
GeNeuro‘s mission is to develop safe and effective treatments
against neurological disorders and autoimmune diseases, such as
multiple sclerosis, by neutralizing causal factors encoded by
HERVs, which represent 8% of human DNA.
For more information, visit: www.geneuro.com.
X | YouTube | LinkedIn
Disclaimer
This press release contains certain forward - looking statements
and estimates concerning GeNeuro’s financial condition, operating
results, strategy, projects and future performance and the markets
in which it operates. Such forward-looking statements and estimates
may be identified by words such as “anticipate,” “believe,” “can,”
“could,” “estimate,” “expect,” “intend,” “is designed to,” “may,”
“might,” “plan,” “potential,” “predict,” “objective,” “should,” or
the negative of these and similar expressions. They incorporate all
topics that are not historical facts. Forward looking statements,
forecasts and estimates are based on management’s current
assumptions and assessment of risks, uncertainties and other
factors, known and unknown, which were deemed to be reasonable at
the time they were made but which may turn out to be incorrect.
Events and outcomes are difficult to predict and depend on factors
beyond the Company’s control. Consequently, the actual results,
financial condition, performances and/or achievements of GeNeuro or
of the industry may turn out to differ materially from the future
results, performances or achievements expressed or implied by these
statements, forecasts and estimates. Owing to these uncertainties,
no representation is made as to the correctness or fairness of
these forward-looking statements, forecasts and estimates.
Furthermore, forward-looking statements, forecasts and estimates
speak only as of the date on which they are made, and GeNeuro
undertakes no obligation to update or revise any of them, whether
as a result of new information, future events or otherwise, except
as required by law.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231127034196/en/
GeNeuro Jesús Martin-Garcia Chairman and CEO +41 22 552
4800 investors@geneuro.com
NewCap (France) Louis-Victor Delouvrier +33 1 44 71 98 52
Arthur Rouillé (media) +33 1 44 71 00 15 geneuro@newcap.eu
GeNeuro (EU:GNRO)
Graphique Historique de l'Action
De Avr 2024 à Mai 2024
GeNeuro (EU:GNRO)
Graphique Historique de l'Action
De Mai 2023 à Mai 2024