GeNeuro

ProTEct-MS Trial Data Reinforce Previous Temelimab Studies

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 studyā€™s small size…

Low Temelimab Doses in RRMS Trial Among Reasons for Poor Results

Low doses selected and underlying inflammatory disease may have confounded the ability of temelimabĀ 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…

Safety Board Says Phase 2 Temelimab Trial Should Move Forward

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…

Enrollment Complete in Phase 2 Trial Testing Temelimab

GeNeuroĀ 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 Institutetā€™s Academic Specialist Center (ASC) in Stockholm, Sweden, has enrolled 42 people with relapsing MS whose…

Study of Temelimab in MS Progression Without Relapse Enrolls 1st Patient

GeNeuro announced that a firstĀ multiple sclerosisĀ (MS)Ā patient has enrolled in its Phase 2 trial assessing the safety and effectiveness of temelimabĀ in people whose disease is progressing in the absence ofĀ relapses. This trial, taking place atĀ the Karolinska Institutetā€™s Academic Specialist Center (ASC), in Stockholm,Ā had been postponedĀ to reduce…

Protein Linked to Microglia Cell Activation and Nerve Fiber Damage in Study That Also Notes Potential Treatment

A proteinĀ 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 theĀ target ofĀ experimental MS treatment calledĀ temelimabĀ (GNbAC1), which showed potential in Phase 2 clinical trials. The…

#ECTRIMS2018 – GNbAC1 Shows Consistent Neuroprotection in RRMS Patients, Phase 2b Study Reports

TreatingĀ relapsing-remitting multiple sclerosis (RRMS) patients with GeNeuroā€™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 studyā€™s inactive population, which refers…

GeNeuro to Develop the MS Clinical Program of GNbAC1 Without Servier

GeNeuroĀ announced it has reacquired from Servier the worldwide rights to commercialize and develop the investigational humanized antibodyĀ GNbAC1Ā 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…

GeNeuro-Servier Antibody Limits RRMS Patients’ Brain Shrinkage, Phase 2b Trial Shows

The laboratory-generated antibodyĀ GNbAC1Ā continued to limitĀ brain shrinkage a year after relapsing-remitting multiple sclerosis patients began receiving it, its developers announced. GeNeuro and ServierĀ were reporting on the 12-month results of aĀ Phase 2b clinical trial. GNbAC1 is a monoclonal antibody that destroys a harmful retroviral protein called pHERV-W which scientists have…

#MSParis2017 – GNbAC1 Promotes Restoration of Protective Myelin Coating, Phase 2b Trial Shows

GeNeuro‘s humanized antibodyĀ GNbAC1Ā promotes the rejuvenation of the myelin coating that protects nerve cells in patients withĀ 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 theĀ Heinrich-Heine-University DĆ¼sseldorfĀ in Germany presented the results at theĀ 7th…

Retroviral RRMS Treatment GNbAC1 Fails Phase 2 Trial, But Research Continues, Say Sponsors

A Phase 2b trial assessingĀ 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 ServierĀ ā€” the two European companies thatĀ jointly developed the drug…

CHANGE-MS Phase 2 Study Fully Enrolled Early, Results Due in Fall

GeNeuro recently announced that it has finished enrolling multiple sclerosis (MS) patients in the CHANGE-MS Phase 2b Ā studyĀ ā€” several months ahead of schedule.Ā The company nowĀ expects to reportĀ topline results in mid- to late autumn rather than at year’s end. ā€œCompleting enrollment in CHANGE-MS several months sooner than previously anticipated…

MS Patients in Clinical Trial of GNbAC1 May Continue with Therapy in Extension Study

Multiple sclerosis (MS) patients now taking part in a Phase 2b clinical trial testingĀ the efficacy and safety of theĀ antibody GNbAC1Ā will be invited to continue withĀ treatment for two more years under a planned extension study, the biopharmaceutical companiesĀ GeNeuroĀ andĀ ServierĀ recently announced. Several MS therapies rely on the capacity of antibodies to…

#ECTRIMS2016 – GeNeuro Reaches Enrollment Halfway Mark in Study of GNbAC1 to Treat Multiple Sclerosis

GeNeuroĀ announced that it has reached ā€” more quickly than expected ā€” the halfway mark for patient enrollment inĀ itsĀ Phase 2b study, CHANGE-MS,Ā assessingĀ GNbAC1 as a therapy forĀ relapsing-remitting multiple sclerosis (RRMS). Patient recruitmentĀ is continuing at sites across Europe. The company alsoĀ reported onĀ theĀ trial’s design in a poster presentation, “A placebo…

First MS Patients in CHANGE-MS Trial Receive Novel Treatment

GeNeuro, a biopharmaceutical company that focusesĀ on novel treatments for autoimmune diseases such as multiple sclerosis (MS), announced thatĀ the first patients with relapsing-remitting multiple sclerosis (RRMS) are underĀ treatment with the companyā€™s leading drug, GNbAC1, in aĀ Phase 2b clinical trial. GNbAC1 is a monoclonal antibody designed to neutralize MSRV-En, a protein…

Experimental RRMS Therapy to Be Tested in a Phase 2b Clinical Trial

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 ā€œCHANGE-MS,ā€ plans to enroll 260 patients across 68 centers acrossĀ theĀ European Union and…

GeNeuro and Servier to Co-Develop Breakthrough Multiple Sclerosis Drug

Neurology and autoimmune therapeutics companyĀ GeNeuro SA has just announced the formation of a partnership with independent French pharmaceutical companyĀ ServierĀ 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…

Novel MS Therapy from GeNeuro Performed Well in Phase 2a Clinical Trial

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…