CHANGE-MS

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…

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…

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…

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…

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…