GeNeuro Is Granted Authorization by the Swiss Health Authority (swissmedic) to Initiate a Phase II Study Evaluating Temelimab in Patients With Severe Neuropsychiatric Post‑COVID Syndromes

Regulatory News:

GeNeuro (Euronext Paris: CH0308403085 - GNRO) (Paris:GNRO), a biopharmaceutical company developing new treatments for neurodegenerative and autoimmune diseases, such as multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS) and the severe neuropsychiatric consequences of COVID-19 (post-COVID), announces today 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 (=Neuropsychiatric) 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.

“The presence of the pathogenic protein W-ENV in post-COVID patients provides a potential biological explanation for the very diverse neuropsychiatric symptoms many suffer from, but also a treatment opportunity by neutralizing W-ENV with temelimab, which is a very well tolerated antibody” said Prof. David Leppert, Chief Medical Officer of GeNeuro. “Our unique ability to test patients for the presence of W-ENV in their blood allows to select and treat only those patients who are likely to benefit from temelimab”.

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.