A phase IIa randomized clinical study testing GNbAC1, a humanized monoclonal antibody against the envelope protein of multiple sclerosis associated endogenous retrovirus in multiple sclerosis patients - A twelve month follow-up.
- Derfuss, T.
- Curtin, F.
- Guebelin, C.
- Bridel, C.
- Rasenack, M.
- Matthey, A.
- Du Pasquier, R.
- Schluep, M.
- Desmeules, J.
- Lang, A.B.
- Perron, H.
- Faucard, R.
- Porchet, H.
- Hartung, H.P.
- Kappos, L.
- Lalive, P.H.
DOIAbstract
GNbAC1 is a humanized monoclonal antibody targeting MSRV-Env, an endogenous retroviral protein, which is expressed in multiple sclerosis (MS) lesions, is pro-inflammatory and inhibits oligodendrocyte precursor cell differentiation. This paper describes the open-label extension up to 12months of a trial testing GNbAC1 in 10 MS patients at 2 and 6mg/kg. The primary objective was to assess GNbAC1 safety, and other objectives were pharmacokinetic and pharmacodynamic assessments. During the extended study, no safety issues occurred in the 8 remaining patients. No anti-GNbAC1 antibodies were detected. GNbAC1 appears well tolerated
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