Testing anti-Virals in MS

Derfuss T, Curtin F, Guebelin C, Bridel C, Rasenack M, Matthey A, Pasquier RD, Schluep M, Desmeules J, Lang AB, Perron H, Faucard R, Porchet H, Hartung HP, Kappos L, Lalive PH.A phase IIa randomised clinical study of GNbAC1, a humanised monoclonal antibody against the envelope protein of multiple sclerosis-associated endogenous retrovirus in multiple sclerosispatients. Mult Scler. 2014 Nov 12. pii: 1352458514554052. [Epub ahead of print]

BACKGROUND:GNbAC1 is an immunoglobulin (IgG4) humanised monoclonal antibody against multiple sclerosis-associated retrovirus (MSRV)-Env, a protein of endogenous retroviral origin, expressed in multiple sclerosis (MS) lesions, which is pro-inflammatory and inhibits oligodendrocyte precursor cell differentiation.
OBJECTIVE:This is a randomised, double-blind placebo-controlled dose-escalation study followed by a six-month open-label phase to test GNbAC1 in MS patients. The primary objective was to assess GNbAC1 safety in MS patients, and the other objectives were pharmacokinetic and pharmacodynamic assessments.
METHODS: Ten MS patients were randomised into two cohorts to receive a single intravenous infusion of GNbAC1/placebo at doses of 2 or 6 mg/kg. Then all patients received five infusions of GNbAC1 at 2 or 6 mg/kg at four-week intervals in an open-label setting. Safety, brain magnetic resonance imaging (MRI), pharmacokinetics, immunogenicity, and MSRV RNA expression were studied.
RESULTS:All patients completed the study. GNbAC1 was well tolerated in all patients. GNbAC1 pharmacokinetics is dose-linear with mean elimination half-life of 27-37 d. Anti-GNbAC1 antibodies were not detected.  MSRV-transcripts showed a decline after the start of treatment. Nine patients had stable brain lesions at MRI.
CONCLUSION: The safety, pharmacokinetic profile, and pharmacodynamic responses to GNbAC1 are favourable in MS patients over a six-month treatment period.

We have just reported on the phase I studies (CLICK) and studies in animals (CLICK) hot on the heels are the phase II studies in MS. Please read the past post for the explanations. This is an antiviral treatment and the antibody appeared to drop evidence of active virus. The trial is too small and short to say what is going to happen.but another approach to give the Charcot project a run for its money.