Assessing the HERV-W Env ANtagonist GNbAC1 for Evaluation in an Open Label Long-term Safety Study in Patients With Multiple Sclerosis

Phase 2 Terminated 220 enrolled GeNeuro SA Institut de Recherches Internationales Servier · collab Les Laboratoires Servier · collab Worldwide Clinical Trials · collab

RandomizedParallel-groupQuadruple-blindTreatment

Summary

The humanised IgG4 monoclonal antibody GNbAC1 targets the envelope protein (Env) of the human endogenous multiple sclerosis-associated retrovirus (HERV-W MSRV), which may play a critical role in multiple sclerosis. The study assesses the long-term safety of GNbAC1 in patients with RRMS and the long-term efficacy of GNbAC1 in terms of MRI outcomes, relapse rate, disability and disease progression.

Timeline

Start: 2017-06-06
Primary completion: 2018-11-14
Completion: 2018-11-14

Outcome

Outcome not reported

Stopped (Business): “Based on R\&D strategic reasons, our co-development Partner financing the study disengaged from the development of GNbAC1.”

Publications

Hartung HP, Derfuss T, Cree BA, Sormani MP, Selmaj K, Stutters J, Prados F, MacManus D, Schneble HM, Lambert E, Porchet H, Glanzman R, Warne D, Curtin F, Kornmann G, Buffet B, Kremer D, Kury P, Leppert D, Ruckle T, Barkhof F. Efficacy and safety of temelimab in multiple sclerosis: Results of a randomized phase 2b and extension study. Mult Scler. 2022 Mar;28(3):429-440. doi: 10.1177/13524585211024997. Epub 2021 Jul 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Temelimab	Monoclonal antibody	6 mg/kg	Intravenous
Subject	Temelimab	Monoclonal antibody	12 mg/kg	Intravenous
Subject	Temelimab	Monoclonal antibody	18 mg/kg	Intravenous