GeNeuro announced it has received the authorization by the Swiss Health Authority (Swissmedic) to initiate a Phase II study evaluating temelimab in patients with severe neuropsychiatric post-COVID syndromes. The GNC-501 study, entitled “Temelimab as a Disease Modifying Therapy in Patients with Neurological, Neuropsychological, and Psychiatric Symptoms in Post-COVID-19 or Post-Acute Sequelae of COVID-19 (PASC) Syndrome”, will enroll 200 patients from Swiss and EU study centres suffering from severe neuropsychiatric syndromes post-COVID. The biomarker-based study will enrol only patients who are also tested positive for the pathogenic protein W-ENV, with the objective to reduce their invalidating conditions.

Large-scale academic studies indicate that more than 10% of people infected with SARS-CoV-2 do not fully recover and/or develop new symptoms, with a high proportion of neurological and/or psychiatric disorders. With more than 500 million confirmed cases of COVID-19 worldwide, including more than 250 million in North America and Western Europe, this problem is now recognized as a major public health emergency, as it is affecting millions of people. GeNeuro is at the forefront in tackling this problem with the first personalized medicine approach with a biomarker-based treatment.

Studies published in 2021 have shown that W-ENV expression was triggered by SARS-CoV-2 in the white blood cells of about 20% of healthy donors, suggesting individual susceptibility. Moreover, recent studies have shown that the pathogenic W-ENV protein is detectable in the blood of 20-40% of post-COVID patients. This presence months after the initial COVID infection supports the biological hypothesis of its role in the long-term syndromes suffered by these patients.

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. The ability to detect W-ENV in post-COVID patients with neuropsychiatric disorders allows to identify a well-defined group of patients that will be treated with the aim of improving their condition.