Geneva, Switzerland–(BUSINESS WIRE)–Regulatory news:
GeNeuro (Euronext Paris: CH0308403085 – GNRO) (Paris:GNRO), a biopharmaceutical company specializing in stopping the causal factors behind 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 enrollment of the first patients in its phase 2 trial evaluating temelimab against the long -COVID at the post-COVID clinic of the University Hospitals of Geneva (lead center), as well as in all the other Swiss clinical centers participating in the study, namely the Inselspital in Bern, the REHAB Basel, the Kantonsspital Graubünden in Chur and the Center Hospitalier du Valais Romand in Sion (for more information, please refer to clinicaltrial.gov or GeNeuro’s website).
Expression of the pathogenic protein W-ENV triggered by SARS-CoV-2 infection, continuing long after resolution of the acute phase, is suspected to have a major role in the persistence of inflammation in many patients with COVID-19 for a long time, and may explain many of the nervous system disorders that patients suffer from, such as cognitive loss and fatigue.
The 6-month multicenter personalized medicine trial will enroll 200 patients positive for the presence of the pathogenic protein W-ENV in their blood. The trial will evaluate temelimab, the anti-W‑ENV antibody developed by GeNeuro, as a disease-modifying treatment in patients with long-term COVID who have difficulty concentrating or fatigue. It will assess the effectiveness of treatment with temelimab over 6 months on the improvement of cognitive disorders or fatigue.
“We are delighted to be able to study this therapeutic approach for patients with disabling long COVID syndromes. We badly need treatments for these often destitute patients,” declared Prof. Idris Guessous, head of primary care medicine at HUG, founder of the long-COVID clinic open at HUG since November 2020, and Principal Investigator of the study. “We hope that this trial targeting the pathogenic protein W-ENV will allow us to develop a personalized medicine approach, treating patients positive for this pathogenic protein..”
“Today, we have very strong evidence for the presence of the pathogenic W-ENV protein in more than 25% of patients in long COVID-19 cohorts, and we have developed a test to confirm its presence in the blood of ‘a patient.“, said Prof. David Leppert, Medical Director of GeNeuro. “The W-ENV protein triggers innate immunity and is pathogenic for cells of the nervous system. This may be a root cause of the debilitating symptoms experienced by a large subset of long-term COVID patients. We hope that its neutralization with temelimab will result in a strong improvement of the disabling 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 doctor Gregory Fretz, chief physician of the medical polyclinic of the Kantonsspital Graubünden and Investigator in the study. “Beyond symptomatic treatments, we need drugs capable of modifying the course of this disease and the W-ENV biological hypothesis is promising.”
The first patients have already been recruited at the five Swiss centers (for more information, please refer to clinicaltrial.gov or the GeNeuro website). Other centers will be opened in the EU. The trial was partially funded by the “Federal COVID-19 Drug Funding Program” to support clinical research on COVID-19 drugs. The first results of the trial are expected in the second half of 2023.
Long-COVID has become a major public health issue worldwide, affecting millions of people. While most patients recover over time, there is a segment of the population whose symptoms remain severe and are deeply affected in their quality of life and ability to work. In the United States alone, the Brookings Institution estimates that about 16 million working-age Americans likely have long COVID today, of which up to 4 million workers are likely out of work due to the disease.
GeNeuro’s mission is to develop safe and effective treatments for neurological disorders and autoimmune diseases, such as multiple sclerosis, by neutralizing the causative factors encoded by endogenous human retroviruses (HERVs), which represent 8% of human DNA.
GeNeuro is based in Geneva, Switzerland, and has R&D facilities in Lyon, France. It holds rights to 17 patent families protecting its technology.
For more information, visit: www.geneuro.com
This press release contains certain forward-looking statements and estimates regarding 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”, “could”, “could”, “estimate”, “expect”, “intend”, “is designed for”, “may”, “could”, “plan”, “potential”, “predict”, “goal”, “should”, or the negative of these and similar expressions. They include all subjects 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 believed to be reasonable at the time they were made. but which may turn out to be incorrect. Events and results are difficult to predict and depend on factors beyond the Company’s control. Accordingly, the actual results, financial condition, performance and/or achievements of GeNeuro or the industry may prove to be materially different from any future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Due to 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 speak only as of the date they are made, and GeNeuro undertakes no obligation to update or revise any of them, whether whether as a result of new information, future events or otherwise, except as required by law.
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