공고 • Jun 28
GeNeuro Announces Results of the Gnc-501 Study in Post-Covid-19 Syndrome GeNeuro SA announced the GNC-501 clinical trial is a Phase 2 study in patients suffering from post-COVID-19 neuropsychiatric diseases, testing temelimab against placebo. The study enrolled over 200 patients in Switzerland, Spain and Italy who had tested positive for HERV-W ENV. The top-line results from this study show that treated patients had no clinically meaningful improvement compared to placebo on the primary endpoint measuring the improvement of fatigue with the PROMIS SF7a test. The majority of secondary endpoints did not show an effect either. The treatment was very well tolerated and safe, consistent with previous clinical trials in other indications. Preliminary analyses suggest that shorter disease duration at time of inclusion, as well as the evolution of the underlying HERV-W ENV status, may have an impact on the efficacy outcome measures. The Company will continue to analyze complete results once they become available, including additional biomarkers. GeNeuro thanks all the study participants, the investigators and all other site personnel for their commitment that made this novel study possible. The learnings from this study will certainly advance the knowledge of this new disease affecting millions of persons worldwide. 공고 • May 18
GeNeuro SA Announces Last Patient Last Visit in Its Post-Covid Trial and Confirms Top-Line Results by End of June 2024 GeNeuro SA announced that the last patient enrolled in the GNC-501 trial of temelimab against post-COVID has now completed the study. The trial "Temelimab as a Disease Modifying Therapy in Patients With Neuropsychiatric Symptoms in Post-COVID 19 or PASC Syndrome" (GNC-501) is a randomized, placebo-controlled, biomarker-based, Phase 2 clinical trial assessing the safety and the efficacy of the treatment with temelimab, a monoclonal antibody neutralizing the pathogenic HERV-W ENV protein. The trial has recruited 203 patients across 14 clinical centres in Switzerland, Spain and Italy. All patients included in the study were tested positive for the expression of the HERV W-ENV protein, which is a key factor in the activation of the innate immune response and is suspected to have a major role in the persistence of inflammation and in the broad spectrum of neurological symptoms affecting patients with post-COVID. Over 1/3 of the patients screened had detectable W-ENV protein expression in blood, suggesting that temelimab could become a relevant treatment option for a large subset of this underserved patient population. All enrolled patients received 6 intravenous infusions of temelimab or placebo (1 to 1 randomization) over 24 weeks. The clinical endpoints will assess the efficacy and the safety of the treatment with temelIMab on the improvement in fatigue and cognitive impairment measures. 공고 • Mar 21
Geneuro SA Announces Appointments of Board of Directors GeNeuro SA at its Extraordinary General Meeting (EGM) of March 18, 2024, approved election of two new Members of the Board of Directors, Mrs. Sandrine Flory, Chief Financial Officer of Institut Mérieux, and Mr. Pascal Lemaire, Chief Financial Officer of Servier. 공고 • Feb 02
GeNeuro SA has completed a Follow-on Equity Offering in the amount of €4.900246 million. GeNeuro SA has completed a Follow-on Equity Offering in the amount of €4.900246 million.
Security Name: Shares
Security Type: Common Stock
Securities Offered: 4,666,901
Price\Range: €1.05
Transaction Features: Subsequent Direct Listing 공고 • Dec 11
Geneuro S.A. Recommends Continuing the Trial Evaluating Temelimab in Long Covid Without Modifications GeNeuro 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 an analysis for futility, the IDMC recommended to "continue the trial without any modifications". The study "Temelimab as a Disease Modifying Therapy in Patients With Neuropsychiatric Symptoms in Post-COVID 19 or PASC Syndrome" is a randomized, placebo-controlled, biomarker-based Phase 2 clinical trial evaluating the effect of temelimab treatment on the clinical course of these symptoms. This trial enrolled 203 patients in 14 clinical centers in Switzerland, Spain and Italy, who were affected by neurological syndromes post-COVID, and who tested positive to the presence of W-ENV in their blood. W-ENV is expected to have a major role in the persistence of inflammation and in the neurological symptoms affecting these patients, and temelimab is a highly specific neutralizing anti-W-ENV-antibody. GeNeuro's precision medicine approach allows to identify, within the millions of patients affected by long-COVID, those for whom the treatment may be relevant. Results are expected in June 2024. 공고 • Nov 29
GeNeuro Announces Completion of Recruitment of its Long-COVID Phase 2 Trial and Confirms Top-Line Results for June 2024 GeNeuro announced the completion of the recruitment of its Phase 2 trial evaluating temelimab against long-COVID. The trial “Temelimab as a Disease Modifying Therapy in Patients With Neuropsychiatric Symptoms in Post-COVID 19 or PASC Syndrome” is a randomized, placebo-controlled, biomarker-based, Phase 2 clinical trial assessing the effect of the treatment with temelimab on the clinical course of these symptoms. The trial has recruited 203 patients across 14 clinical centres in Switzerland, Spain and Italy. All enrolled patients receive 6 intravenous infusions of temelimab or placebo (1 to 1 randomization) over 24 weeks. The clinical endpoints will assess the efficacy and the safety of the treatment with temelimab on the improvement in fatigue and cognitive impairment measures. The recruitment of the trial has already demonstrated that the expression of the pathogenic W-ENV protein, triggered by the SARS-CoV-2 infection, may continue long after the acute phase has been resolved. Over one third of the patients presenting long-COVID syndromes who were screened were positive to the presence of W-ENV in their blood. W-ENV is suspected to have a major role in the persistence of inflammation and in the neurological symptoms affecting these patients, and temelimab is a highly specific neutralizing anti-W-ENV-antibody. GeNeuro’s precision medicine approach allows to identify, within the millions of patients affected by long-COVID, those for whom the treatment may be relevant. The development of temelimab (GNbAC1) is the result of more than 25 years of research into human endogenous retroviruses (HERVs), including 15 years within Institut Mérieux and INSERM before GeNeuro was founded in 2006. HERVs have been incorporated into the human genome during the evolution of mankind and typically remain “silent genes”, but may be activated under certain conditions and were found to be involved in the development of auto-immune diseases. The viral envelope protein encoded by the HERV-W family (W-ENV) has been found to be pro-inflammatory and pathogenic to nervous system cells. W-ENV is found in the brains of MS patients, and particularly in active lesions. In two Phase II multiple sclerosis trials Temelimab has shown promising results on MRI features and liquid biomarkers related to neurodegenerative processes such as brain atrophy. Temelimab is a neutralizing anti-W-ENV-antibody; by this capacity it simultaneously blocks inflammatory and neurodegenerative processes. Given that W-ENV has no known physiological function, temelimab has demonstrated a good safety and tolerability profile in the current study, with no effect on the patient’s immune system, which bears out the profile observed in all clinical trials carried out to date. 
