GeNeuro Announces Last Patient Last Visit in its Post-COVID Trial and Confirms Top-Line Results by End of June 2024
16 Mai 2024 - 8:00AM
Business Wire
- The GNC-501 study against Post-Covid completed the last
patient visit
- The study’s objective is to evaluate the efficacy and safety
of temelimab on the improvement of fatigue and cognitive impairment
measures associated with Post-Covid
- With 203 patients enrolled, GNC-501 is one of the largest
randomized double-blind placebo-controlled precision-medicine
trials in the post-COVID indication
- GeNeuro confirms the timelines for the finalization of the
trial , with top-line data expected by the end of June
2024.
Regulatory News:
GeNeuro (Euronext Paris: CH0308403085 – GNRO), a
biopharmaceutical company developing therapies for patients with
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 that the last patient enrolled in the GNC-501 trial of
temelimab against post-COVID has now completed the study.
The trial “Temelimab as a Disease Modifying Therapy in Patients
With Neuropsychiatric Symptoms in Post-COVID 19 or PASC Syndrome”
(GNC-501) is a randomized, placebo-controlled, biomarker-based,
Phase 2 clinical trial assessing the safety and the efficacy of the
treatment with temelimab, a monoclonal antibody neutralizing the
pathogenic HERV-W ENV protein. The trial has recruited 203 patients
across 14 clinical centres in Switzerland, Spain and Italy.
All patients included in the study were tested positive for the
expression of the HERV W-ENV protein, which is a key factor in the
activation of the innate immune response and is suspected to have a
major role in the persistence of inflammation and in the broad
spectrum of neurological symptoms affecting patients with
post-COVID. Over 1/3 of the patients screened had detectable W-ENV
protein expression in blood, suggesting that temelimab could become
a relevant treatment option for a large subset of this underserved
patient population.
All enrolled patients received 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.
“With this last visit of the last patient, we have reached a key
step towards the finalization of the GNC-501 study exploring a
potential precision-medicine based treatment option for subjects
suffering from post-COVID,” said Dr. Anke Post, Chief Medical
Officer of GeNeuro. “We thank all patients who have agreed to
participate in this study, the largest of its kind up to date, and
hope that the results at the end of June will confirm the potential
of temelimab to relieve persistent symptoms such as fatigue and to
impact the disease burden.”
About temelimab
The development of temelimab 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 brain of patients with MS as well as
COVID-19 and post-COVID. In two Phase II MS trials, temelimab has
shown target engagement and 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 all clinical trials carried out to
date.
About GeNeuro
GeNeuro‘s mission is to leverage HERV biology to develop safe
and effective treatments for the benefit of patients, by
neutralizing causal factors encoded by HERVs that represent 8% of
human DNA.
GeNeuro is based in Geneva, Switzerland and has R&D
facilities in Lyon, France.
For more information, visit: www.geneuro.com
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,”
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“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.
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GeNeuro Jesús Martin-Garcia Chairman and CEO +41 22 552
4800 investors@geneuro.com NewCap (France) 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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