Clinical Trial Assessing the HERV-W Env Antagonist GNbAC1 for Efficacy in MS

Phase 2 Completed 270 enrolled GeNeuro SA Institut de Recherches Internationales Servier · collab Les Laboratoires Servier (LLS) · 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 (MS). This study evaluates the effect on MRI lesions parameters, the safety and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis.

Timeline

Start: 2016-04
Primary completion: 2017-08
Completion: 2017-12

Outcome

Missed primary endpoint

paper The primary endpoint was not met. PMID 34240656 ↗

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