GENEVA--(BUSINESS WIRE)--
Regulatory News:
GeNeuro (Euronext Paris: CH0308403085 - GNRO) (Paris:GNRO), a biopharmaceutical company developing novel treatments for neurodegenerative and autoimmune diseases, with final Phase II results in multiple sclerosis expected in March 2022, announced today that its development in Long-COVID is one of the four projects selected by the Swiss Federal Office of Public Health (FOPH) and that it will receive in this regard a grant of 6.7 million Swiss francs (€6.4 million) to co-fund a Phase 2 clinical trial to treat patients with long-standing COVID who exhibit severe neurological and psychiatric ("neuropsychiatric") symptoms.
"We are extremely grateful for this funding from the FOPH, which will allow us to test GeNeuro's treatment for the neuropsychiatric forms of Long-COVID," said Jesús Martin-Garcia, CEO of GeNeuro. "The efforts conducted with our academic partners have shown the presence of the pathogenic protein HERV-W ENV ("W-ENV") in Long-COVID patients and could explain the neuropsychiatric syndromes that affect them. Our approach is one of the first concrete leads to explain these problems, and also potentially to treat them with temelimab, GeNeuro's anti-W-ENV antibody."
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 265 million confirmed cases of COVID-19 worldwide, including more than 100 million in the US and Europe, this problem is now recognized as a major public health emergency, as it is affecting millions of people.
A first publication in the Lancet EBioMedicine in April 2021 showed the systematic presence of the pathogenic protein W-ENV in hospitalized COVID-19 patients and its association with disease severity. Since then, GeNeuro has been involved in numerous academic efforts to understand the role of this
W-ENV protein, which is known to have a pro-inflammatory effect and pathogenicity on nervous system cells, in the syndromes suffered by COVID-19 patients, months after the infectious phase has ended.
Today, GeNeuro is able to test the presence of W-ENV in the blood of patients suffering from Long-COVID, and is developing temelimab, a specific anti-W-ENV antibody, already being tested against neurodegeneration in multiple sclerosis. The clinical trial supported by the FOPH will be a double-blind, randomized, placebo-controlled clinical study on Long-COVID patients with severe neuropsychiatric symptoms that prevent them from continuing their daily and professional activities. This study will start in the spring of next year.
About W-ENV and COVID-19
It has been shown that SARS-CoV-2 triggers the expression of W-ENV in the white blood cells of approximately 20% of healthy donors, suggesting a genetic and/or epigenetic susceptibility to the production of this pathogenic protein upon exposure to the virus.
W-ENV expression was detected in lymphocytes from hospitalized COVID-19 patients, not in healthy subjects, and the level of W-ENV correlated with the severity of disease progression.
Post-mortem studies of COVID-19 patients have now shown that W-ENV expression can be triggered in the brain, particularly on microglial cells as well as in endothelial cells of brain blood vessels. Until now, W-ENV expression in the brain had only been observed in patients who had died from diseases such as multiple sclerosis, suggesting a role in fueling long-term neurodegeneration. W-ENV is not found in the brains of neurological controls such as patients with Alzheimer's or Parkinson's disease.
Analyses of samples from the first pilot cohorts of patients with post-COVID depressive and cognitive symptoms have shown that W-ENV protein is present at consistently detectable and sometimes elevated levels in the blood. This may allow early identification and treatment of patients who could benefit from anti-W-ENV therapy with temelimab.
About GeNeuro
GeNeuro's mission is to develop safe and effective treatments for neurological disorders and autoimmune diseases, such as multiple sclerosis, by neutralizing causative factors induced by human endogenous retroviruses (HERVs), which represent 8% of the human genome.
Based in Geneva, Switzerland, and with an R&D center in Lyon, France, GeNeuro holds the rights to 17 patent families that protect its technology.
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Forward-looking statements: This document contains forward-looking statements and estimates about the financial condition, results of operations, strategy, plans and future performance of GeNeuro and the market in which it operates. Some of these statements, forecasts and estimates can be identified by the use of words such as, without limitation, "believes", "anticipates", "expects", "projects", "plans", "seeks", "estimates", "may", "will" and "continue" and other similar expressions. They include all matters that are not historical facts. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were believed to be reasonable when made but which may not prove to be correct. Actual events are difficult to predict and may depend on factors beyond the Company's control. Consequently, GeNeuro's actual results, financial conditions, performance or achievements, or industry results, may differ materially from future results, performance or achievements as expressed or implied by such statements, forecasts and estimates. In addition, the forward-looking statements, forecasts and estimates speak only as of the date of this document. GeNeuro disclaims any obligation to update any such forward-looking statements, forecasts or estimates to reflect any change in the Company's expectations with respect thereto, or any change in events, conditions or circumstances on which any such statements, forecasts or estimates are based, except as required by French law.
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