Geneva - GeNeuro (Euronext Paris: CH0308403085 - 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 that, as planned in the Study Protocol, the Independent Data Monitoring Committee met to review the unblinded safety and efficacy data of the first 90 patients after three months of treatment.
Based on the planned interim analysis of efficacy and safety data, which included a futility analysis, the Committee recommended continuing the trial without any modifications.
The Temelimab as a Disease Modifying Therapy in Patients With Neuropsychiatric Symptoms in Post-COVID 19 or PASC Syndrome trial is a randomized, placebo-controlled, biomarker-based, phase 2 clinical trial evaluating the treatment effect of temelimab on the clinical course of these symptoms.
The trial recruited 203 patients from 14 clinical centers in Switzerland, Spain and Italy, all affected by post-COVID neurological syndromes, and who were diagnosed positive for the presence of W-ENV in their blood. W-ENV is suspected of playing a determining role in the persistence of inflammation and in the neurological symptoms affecting these patients. Temelimab is a highly specific anti-W-ENV antibody capable of neutralizing W-ENV.
GeNeuro s precision medicine approach makes it possible to identify, among the millions of patients affected by Long COVID, those for whom treatment with temelimab could be relevant.
About Temelimab
The development of temelimab (GNbAC1) is the result of more than 25 years of research on human endogenous retroviruses (HERV), including 15 years at the Institut Merieux and INSERM before the creation of GeNeuro in 2006. HERVs were incorporated into the human genome during the evolution of humanity and typically remain silent genes , but which can be activated under certain conditions and have been linked to the development of autoimmune diseases. The viral envelope protein encoded by the HERV-W (W-ENV) family has been shown to be pro-inflammatory and pathogenic to cells of the nervous system. The W-ENV protein is present in the brains of patients with multiple sclerosis, particularly in active lesions. In two Phase II trials in multiple sclerosis, Temelimab showed promising results on MRI features and liquid biomarkers related to neurodegenerative processes such as brain atrophy.
Temelimab is a neutralizing anti-W-ENV antibody, which allows it to simultaneously block inflammatory and neurodegenerative processes. Since W-ENV has no known physiological function, temelimab showed a good safety and tolerability profile in the current study, with no effect on the patient s immune system, confirming the profile observed in all clinical trials carried out to date.
About GeNeuro
GeNeuro s mission is to develop safe and effective treatments for neurological disorders and autoimmune diseases, such as multiple sclerosis, by neutralizing the causal factors encoded by HERVs, which make up 8% of human DNA.
Disclaimer
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