GeNeuro has enrolled its first participants to test temelimab, a drug for treating cognitive issues and fatigue in Long COVID patients.
A new medication to treat Long COVID symptoms may soon be available. Switzerland-based biotech company GeNeuro has started enrolling participants for its phase 2 clinical trial to test the efficacy of experimental drug temelimab for treating Long COVID-related fatigue and cognitive impairment.
Temelimab is an antibody that targets a protein called HERV-W env, or just W-ENV, which has been linked to various neurological and psychiatric disorders such as multiple sclerosis (MS) and schizophrenia, as well as to inflammatory abnormalities.
The protein, easily detected with a blood test, has been seen in over 25% of Long COVID patients. GeNeuro’s CEO, Jésus Martin-Garcia, says that W-ENV is pathogenic, and is triggered by infection with the SARS-CoV-2 virus.
“W-ENV protein is only found in situations of disease, such as acute COVID or Long COVID, but not in healthy persons,” he explains. “The pathogenic properties of W-ENV are well-documented in the literature…with a direct pathogenic effect on nervous system cells.”
“Finding it in brain tissue and blood circulation of Long COVID patients, now up to two years after the original infection,” he continues, “may explain some of the observed phenomena such as cytokine upregulation and tissue damage in the central nervous system.”
GeNeuro develops treatments for neurological and autoimmune disorders like multiple sclerosis (MS) and Lou Gehrig’s disease. The company recently reported study data showing that temelimab had additional protective benefits against neurodegeneration in MS patients who had already taken an anti-inflammatory medication.
“We decided to start a program against Long COVID based on the evidence that SARS-CoV-2 triggers the expression of W-ENV in susceptible individuals,” says Martin-Garcia. “We have been able to act fast because we already had an anti-W-ENV antibody we have developed for MS, and over 500 patient-years of clinical experience with it, showing an excellent tolerability profile.”
He also says that the estimated 25% incidence of W-ENV in Long COVID patients is conservative. “We have detected W-ENV in several Long COVID cohorts from the U.S. and the E.U. There were 25 to 50% of patients positive, depending on the cohorts.”
Researchers for the six-month phase 2 trial hope to test the drug in 200 Long COVID patients across five Swiss locations. Eligibility for the study includes confirmation that the W-ENV protein is present, and neuropsychiatric symptoms that interfere with day-to-day activities and work performance.
“Neutralizing this protein with temelimab, an anti-HERV-W antibody with a very good tolerability profile, is a good thing to do to stop inflammation and damage to the central nervous system,” Martin-Garcia says. “The clinical trial will be able to determine if this treatment resolves, in part or in full, the very invalidating symptoms these patients suffer.”
*Arthur, R. (2022, November 22). Long-COVID personalized medicine enters Phase 2 trial. BioPharma-Reporter. https://www.biopharma-reporter.com/Article/2022/11/22/Long-COVID-personalized-medicine-enters-Phase-2-trial
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