GENEVA, Switzerland–(BUSINESS WIRE)–Regulatory News:

GeNeuro (Euronext Paris: CH0308403085 – GNRO) (Paris:GNRO), a biopharmaceutical company focused on stopping causal factors driving the progression of neurodegenerative and autoimmune diseases such as multiple sclerosis (MS), amyotrophic lateral sclerosis (ALS) and Post-Acute Sequelae of COVID-19 (PASC, long-COVID or post-COVID), today announced the recruitment of first patients in its Phase 2 trial evaluating temelimab against long-COVID at the Geneva University Hospitals post-COVID clinic (lead centre), as well as in all the other Swiss clinical centres participating to the study, i.e., Inselspital in Bern, REHAB Basel, Kantonsspital Graubünden in Chur and the Centre Hospitalier du Valais Romand in Sion (for more information, please refer to clinical trials.gov or to GeNeuro’s web site).

The expression of the pathogenic W-ENV protein triggered by the SARS-CoV-2 infection, continuing long after the acute phase has been resolved, is suspected to have a major role in the persistence of inflammation in many long-COVID patients, and may explain many of the nervous system disorders that patients experience, such as cognitive losses and fatigue.

The 6-month multicentre personalized medicine trial will recruit 200 patients who are positive for the presence of the pathogenic W-ENV protein in their blood. The trial will evaluate temelimab, the anti-W‑ENV antibody developed by GeNeuro, as a Disease Modifying Therapy in long-COVID patients suffering from concentration or fatigue problems. It will assess the efficacy of the treatment with temelimab over 6 months on improvement in cognitive impairment or fatigue.

We are delighted to be able to study this therapeutic approach for patients who are suffering from impairing long-COVID syndromes. We are in dire need of treatments for these patients who are often helpless,said Prof. Idris Guessous, Head of the Department of Primary Care Medicine of HUG, founder of the long-COVID clinic opened at the HUG since November 2020, and Principal Investigator of the study. “We hope that this trial targeting the W-ENV pathogenic protein will allow us to develop a personalized medicine approach, treating patients who are positive for this pathogenic protein.”

Today we have very strong evidence of the presence of the pathogenic W-ENV protein in over 25% of patients in long-COVID cohorts, and we have developed a test to confirm its presence in a patient’s blood,” said Prof. David Leppert, Chief Medical Officer of GeNeuro. “The W-ENV protein triggers innate immunity and is pathogenic to nervous system cells. It may be a root cause for the debilitating symptoms experienced by a large subset of long-COVID patients. We hope that its neutralization with temelimab will result in a strong improvement in the debilitating syndromes experienced by these patients.”

“I contacted GeNeuro to participate in this study because we have a strong demand from patients suffering from severe forms of long-COVID”, said Dr. Gregory Fretz, Head Physician of the Medizinische Poliklinik at the Kantonsspital Graubünden and Investigator in the study. “Beyond symptomatic treatments, we need drugs that can modify the course of this disease and the W-ENV biological hypothesis is promising.”

First patients have already been enrolled in all five Swiss Centres (for more information, please refer to clinical trials.gov or to GeNeuro’s web site). Further centers will be opened in the EU. The trial was partly funded by the Swiss “Federal Funding Programme for COVID-19 Medicines” to support clinical research into drugs for COVID-19. Top-line results of the trial are expected in the second half of 2023.

Long-COVID has become a major public-health concern worldwide, affecting millions of individuals. While most patients recover over time, there is a part of the population whose symptoms remain severe and are deeply affected in their quality of life and ability to work. In the US alone, the Brookings Institution estimates that around 16 million working-age Americans likely have long-COVID today, of which as many as 4 million workers are likely out of work due to this disease.

About GeNeuro

GeNeuro‘s mission is to develop safe and effective treatments against neurological disorders and autoimmune diseases, such as multiple sclerosis, by neutralizing causal factors encoded by human endogenous retroviruses (HERVs), which represent 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 protecting its technology.

For more information, visit: www.geneuro.com

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This press release contains certain forward – looking statements and estimates concerning GeNeuro’s financial condition, operating results, strategy, projects and future performance and the markets in which it operates. Such forward-looking statements and estimates may be identified by words, such as “anticipate,” “believe,” “can,” “could,” “estimate,” “expect,” “intend,” “is designed to,” “may,” “might,” “plan,” “potential,” “predict,” “objective,” “should,” or the negative of these and similar expressions. They incorporate all topics that are not historical facts. Forward looking statements, forecasts and estimates are based on management’s current assumptions and assessment of risks, uncertainties and other factors, known and unknown, which were deemed to be reasonable at the time they were made but which may turn out to be incorrect. Events and outcomes are difficult to predict and depend on factors beyond the company’s control. Consequently, the actual results, financial condition, performances and/or achievements of GeNeuro or of the industry may turn out to differ materially from the future results, performances or achievements expressed or implied by these statements, forecasts and estimates. Owing to these uncertainties, no representation is made as to the correctness or fairness of these forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates speak only as of the date on which they are made, and GeNeuro undertakes no obligation to update or revise any of them, whether as a result of new information, future events or otherwise, except as required by law.



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