Independent Data Monitoring Committee Recommends Continuing the Trial Evaluating Temelimab in Long COVID Without Any Modifications
11 Décembre 2023 - 8:00AM
Business Wire
- As planned in the Protocol of the Study, the Independent
Data Monitoring Committee (IDMC) met to review the unblinded safety
and efficacy data of the first 90 patients after three months of
treatment.
- Based on the planned interim analysis of efficacy and safety
data, which included an analysis for futility, the IDMC recommended
to “continue the trial without any modifications”.
- The study is evaluating the efficacy and safety of treatment
by temelimab in terms of improving measures of fatigue and
cognitive impairment. Results are expected in June 2024.
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 that, as planned in the
Study Protocol, the Independent Data Monitoring Committee met to
review the unblinded safety and efficacy data of the first 90
patients after three months of treatment.
Based on the planned interim analysis of efficacy and safety
data, which included an analysis for futility, the IDMC recommended
to “continue the trial without any modifications”.
The study “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 evaluating the effect of temelimab treatment on the
clinical course of these symptoms.
This trial enrolled 203 patients in 14 clinical centers in
Switzerland, Spain and Italy, who were affected by neurological
syndromes post-COVID, and who tested 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.
Results are expected in June 2024.
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.
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GeNeuro Jesús Martin-Garcia President 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
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