Higher doses of temelimab were generally safe and resulted in beneficial trends on key neurodegeneration markers in adults with relapsing forms of multiple sclerosis (MS) who already were on rituximab treatment, according to top-line data from the ProTEct-MS Phase 2 clinical trial. While the study’s small size…
GeNeuro
Combined Data May Predict Person’s Risk of Advancing From CIS to MS Clinically isolated syndrome is sometimes called “early MS.” It’s the diagnosis used when someone’s symptoms don’t quite look like MS, but it does appear that MS is lurking. It may take years for an actual…
A Phase 2 clinical trial into the safety and tolerability of higher-dose temelimab as a potential therapy for relapsing forms of multiple sclerosis (MS) is now complete, and top-line data is expected by late March, its developer, GeNeuro, announced. The ProTEct-MS Phase 2 trial (NCT04480307), conducted at the Karolinska…
The first patient who completed the ProTEct-MS Phase 2 clinical trial assessing temelimab as a treatment for relapsing forms of multiple sclerosis (MS) has entered the trial’s extension part. In the open-label extension trial, patients will switch to or continue to receive temelimab at least until next spring, when…
Low doses selected and underlying inflammatory disease may have confounded the ability of temelimab to significantly affect neuroinflammation in a Phase 2 trial in relapsing-remitting multiple sclerosis (RRMS) patients. GeNeuro‘s investigational MS therapy did, however, show other evidence of clinical benefit that supports its continued development, researchers…
NeurologyLive, CMSC Launch Expert Video Series ‘Cure Connections’ This series of 13 videos, designed for healthcare professionals, focuses on diagnosing MS, its psychological impact, managing symptoms, and treatments. Quality-of-life issues, fatigue, and patient support networks also will be discussed. I hope general neurologists will watch it, not just MS…
A Phase 2a clinical trial evaluating GeNeuro‘s investigational antibody temelimab as a treatment for relapsing multiple sclerosis (MS) should continue as planned, without modifications. That’s the recommendation of a Drug Safety Monitoring Board, an independent committee of clinical research experts, which was evaluating the trial of the…
GeNeuro has completed patient enrollment in its ProTEct-MS Phase 2 clinical trial evaluating temelimab as a treatment for multiple sclerosis (MS), the company announced. The study (NCT04480307), taking place at the Karolinska Institutet’s Academic Specialist Center (ASC) in Stockholm, Sweden, has enrolled 42 people with relapsing MS whose…
Temelimab, GeNeuro’s investigative treatment for multiple sclerosis (MS), showed a favorable safety profile when given alongside rituximab, according to preclinical safety experiments performed in preparation for the company’s new Phase 2 trial involving patients with relapsing MS. Data from the preclinical experiments, along with details of…
GeNeuro announced that a first multiple sclerosis (MS) patient has enrolled in its Phase 2 trial assessing the safety and effectiveness of temelimab in people whose disease is progressing in the absence of relapses. This trial, taking place at the Karolinska Institutet’s Academic Specialist Center (ASC), in Stockholm, had been postponed to reduce…
A planned Phase 2 clinical trial of a potential treatment for progressive multiple sclerosis has been postponed to keep hospital resources open to treat people with COVID-19 during the ongoing global outbreak, and to reduce the risk of exposure to MS patients, GeNeuro, the investigate therapy’s developer, announced. The…
GeNeuro is collaborating with clinical researchers at the Karolinska Institutet and the Academic Specialist Center (ASC) in Stockholm to open a new clinical trial of temelimab in people whose multiple sclerosis (MS) is progressing in the absence of relapses. Fredrik Piehl, MD, PhD, a professor of neurology at…
A protein leads to nerve fiber and myelin damage, particularly in progressive forms of multiple sclerosis, by activating brain immune cells called microglia, according to a new study. Its researchers also noted this protein is the target of experimental MS treatment called temelimab (GNbAC1), which showed potential in Phase 2 clinical trials. The…
Two-year treatment with temelimab reduced brain atrophy, or shrinkage, preserved myelin, and reduced disease progression in patients with relapsing-remitting multiple sclerosis (RRMS), according to findings from an extension study of a Phase 2b clinical trial. Temelimab, previously known as GNbAC1, is a monoclonal antibody that neutralizes the MS-associated human…
MS Patients Sought to Test Alternative Chronic Pain Treatment Methods Do you have serious pain issues along with your MS? If so, you might be interested in this study that’s looking for participants. By the way, who says that pain isn’t an MS symptom? A clinical trial…
GeNeuro has reported positive data from a Phase 1 clinical trial (NCT03574428) evaluating the safety and tolerability of high doses of GNbAC1, developed for the treatment of neurological and autoimmune disorders, including multiple sclerosis (MS). The company also announced that the World Health…
#ECTRIMS2018 – GNbAC1 Shows Consistent Neuroprotection in RRMS Patients, Phase 2b Study Reports
Treating relapsing-remitting multiple sclerosis (RRMS) patients with GeNeuro’s investigational compound GNbAC1 lessened brain atrophy and lesion load and suggested myelin preservation, according to results of a Phase 2b study. Importantly, monthly intravenous GNbAC1 administration for 48 weeks also had neuroprotective effects in the study’s inactive population, which refers…
GeNeuro announced it has reacquired from Servier the worldwide rights to commercialize and develop the investigational humanized antibody GNbAC1 for the treatment of multiple sclerosis (MS). The decision came after Servier, a European company which, together with GeNeuro, developed the GNbAC1 program, declined to continue developing the therapy due to…
The laboratory-generated antibody GNbAC1 continued to limit brain shrinkage a year after relapsing-remitting multiple sclerosis patients began receiving it, its developers announced. GeNeuro and Servier were reporting on the 12-month results of a Phase 2b clinical trial. GNbAC1 is a monoclonal antibody that destroys a harmful retroviral protein called pHERV-W which scientists have…
GeNeuro‘s humanized antibody GNbAC1 promotes the rejuvenation of the myelin coating that protects nerve cells in patients with relapsing-remitting multiple sclerosis, or RRMS, a Phase 2 clinical trial shows. The treatment is also safe, the study showed. Dr. Hans-Peter Hartung of the Heinrich-Heine-University Düsseldorf in Germany presented the results at the 7th…
A Phase 2b trial assessing the experimental retroviral-targeting treatment GNbAC1 in patients with relapsing-remitting multiple sclerosis (RRMS) failed to meet its primary goal of reducing brain lesions and other signs of brain inflammation within six months. But researchers at GeNeuro and Servier — the two European companies that jointly developed the drug…
GeNeuro recently announced that it has finished enrolling multiple sclerosis (MS) patients in the CHANGE-MS Phase 2b study — several months ahead of schedule. The company now expects to report topline results in mid- to late autumn rather than at year’s end. “Completing enrollment in CHANGE-MS several months sooner than previously anticipated…
Multiple sclerosis (MS) patients now taking part in a Phase 2b clinical trial testing the efficacy and safety of the antibody GNbAC1 will be invited to continue with treatment for two more years under a planned extension study, the biopharmaceutical companies GeNeuro and Servier recently announced. Several MS therapies rely on the capacity of antibodies to…
GeNeuro announced that it has reached — more quickly than expected — the halfway mark for patient enrollment in its Phase 2b study, CHANGE-MS, assessing GNbAC1 as a therapy for relapsing-remitting multiple sclerosis (RRMS). Patient recruitment is continuing at sites across Europe. The company also reported on the trial’s design in a poster presentation, “A placebo…
GeNeuro, a biopharmaceutical company that focuses on novel treatments for autoimmune diseases such as multiple sclerosis (MS), announced that the first patients with relapsing-remitting multiple sclerosis (RRMS) are under treatment with the company’s leading drug, GNbAC1, in a Phase 2b clinical trial. GNbAC1 is a monoclonal antibody designed to neutralize MSRV-En, a protein…
GeNeuro, a company developing therapies for neurological and autoimmune disorders, recently announced the initiation of a Phase 2b clinical trial to assess its lead investigational antibody GNbAC1 in patients with relapsing-remitting multiple sclerosis (RRMS). The trial, called “CHANGE-MS,” plans to enroll 260 patients across 68 centers across the European Union and…
Neurology and autoimmune therapeutics company GeNeuro SA has just announced the formation of a partnership with independent French pharmaceutical company Servier for the co-development and marketing of GNbAC1 for Multiple Sclerosis (MS). It is the first humanized monocloncal antibody treatment formulated to address one of this disease’s causal factors, making it…
A novel therapeutic from GeNeuro to treat multiple sclerosis showed promising results in a one-year, open-label extension phase 2a clinical trial. GeNeuro tested its first-in-class GNbAC1 monoclonal antibody in ten multiple sclerosis patients, nine of whom have primary or secondary progressive multiple sclerosis. “We are very excited by the…