GeNeuro has received approval from the Swiss Health Authority (Swissmedic) to initiate a Phase II study evaluating temelimab in patients with severe post-COVID neuropsychiatric syndromes

  • Use of GeNeuro’s temelimab as part of the first personalized medicine approach in severe post-COVID neuropsychiatric syndromes
  • Biomarker-based study to detect and neutralize the presence of the pathogenic protein W-ENV with temelimab
  • GeNeuro previously received a €6.4 million grant from the Swiss Federal Office of Health (OFSP) to co-finance this clinical trial

GENVE–(BUSINESS WIRE)–Regulatory news:

GeNeuro (Euronext Paris: CH0308403085 – GNRO) (Paris:GNRO), a biopharmaceutical company developing novel treatments for neurodegenerative and autoimmune diseases, such as multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS) and the consequences of severe neuropsychiatric disorders of COVID-19 (post-COVID), today announces that it has received approval from the Swiss Health Authority (Swissmedic) to initiate a Phase II study evaluating temelimab in patients suffering from post-COVID severe neuropsychiatric disorders.

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 consequences of the COVID-19 (PASC) syndrome”, will involve the recruitment of 200 patients from Swiss and European study centers suffering from severe post-COVID neuropsychiatric syndromes. This biomarker-based study will only recruit patients who also test positive for the pathogenic protein W-ENV with the aim of reducing their debilitating conditions.

The presence of the pathogenic protein W-ENV in post-COVID patients offers a possible biological explanation for the diverse neuropsychiatric symptoms that many patients suffer from, but also offers a treatment option by neutralizing W-ENV with temelimab, a highly tolerated antibody. “, said Professor David Leppert, Medical Director of GeNeuro† †Our unique ability to test for the presence of W-ENV in patients’ blood allows us 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 percentage 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 affects millions of people. GeNeuro is at the forefront of combating this problem by providing the first approach to personalized medicine with biomarker-based treatment.

Studies published in 2021 showed that W-ENV expression was mediated by SARS-CoV-2 in the white blood cells of approximately 20% of healthy donors, indicating individual susceptibility. In addition, recent studies have shown that the pathogenic protein W-ENV is detectable in the blood of approximately 20-40% of post-COVID patients. The presence of W-ENV several months after the initial COVID-19 infection supports the biological hypothesis of its role in the long-term syndromes these patients suffer from.

GeNeuro has developed temelimab, a specific antibody against the W-ENV protein, which has shown promising results in phase II studies in multiple sclerosis against MRI markers of neurodegeneration. Temelimab has demonstrated 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 makes it possible to identify a well-defined group of patients who will be treated with the aim of improving their condition.

As previously mentioned, GeNeuro received a €6.4 million grant from the Swiss Federal Office of Health (FOPH) to co-finance the Phase 2 clinical trial for the treatment of post-COVID patients with symptoms. W-ENV antibody.

About GeNeuro

GeNeuro’s mission is to develop safe and effective treatments for neurological disorders and autoimmune diseases, such as multiple sclerosis, by neutralizing causal factors encoded by HERVs, which make up 8% of human DNA.

GeNeuro is based in Geneva, Switzerland, and has R&D facilities in Lyon, France. It has rights to 17 patent families that protect its technology.

For more information, please visit the website: www.geneuro.com

Warning

This press release contains certain forward-looking statements and estimates with respect to the financial condition, results of operations, strategy, plans and future performance of GeNeuro and the markets in which it operates. These forward-looking statements and estimates can be identified by words such as “anticipate”, “believe”, “may”, “estimate”, “expect”, “intend”, “intend to”, “may”, “could”, “plan”, “potential”, “forecast”, “target”, “should”, or the negative form of these and other similar expressions. They include all topics that are not historical facts. Forward-looking statements, Forecasts and estimates are based on management’s current assumptions and assessments of risks, uncertainties and other factors, known and unknown, believed to be reasonable at the time they were made, but may prove to be incorrect. Events and results are difficult to predict and depend on factors outside of the company’s control and accordingly the actual results, financial condition, performance and/or performance of GeNeuro or industry differ materially from any future results, performance or performance expressed or implied by such statements, forecasts and estimates. Because of these uncertainties, no representation is made as to the accuracy or correctness of such forward-looking statements, forecasts and estimates. Further, forward-looking statements, forecasts and estimates are only valid as of the date they are made, and GeNeuro undertakes no obligation to update or revise them, whether as a result of new information, future events or otherwise, except as required by law. .

contacts

GeNeuro
Jesus Martin Garcia

President and CEO

+41 22 552 4800

investors@geneuro.com

NewCap (France)
Mathilde Bohin / Louis-Victor Delouvrier (investors)

+33 1 44 71 98 52

Arthur Rouille (media)

+33 1 44 71 00 15

geneuro@newcap.eu

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