GNbAC1 is a selective monoclonal antibody currently in development for treating relapsing-remitting multiple sclerosis (RRMS). Commonly used to treat cancer, monoclonal antibodies are laboratory-produced molecules engineered to serve as substitute antibodies that can restore, enhance, or mimic the immune system’s attack on disease.
In multiple sclerosis, brain lesions that occur with the disease contain a protein called MSRV-Env (multiple sclerosis associated retrovirus envelope protein.) The MSRV-Env protein may induce chronic inflammation of immune cells, making it difficult for precursor oligodendrocytes (glial cells) to become myelinating oligodendrocytes (which create myelin to protect nerves). In vitro and in vivo studies showed that GNbAC1 neutralizes MSRV-Env disease-causing effects, either by blocking a key factor that promotes the inflammation on the lesion, or by allowing the remyelination repair process to restart. It is considered an innovative therapeutic approach to MS.
Phase 1 studies of GNbAC1 in healthy participants (NCT01699555 and NCT02452996), and in people with MS (NCT01639300) showed excellent safety profiles and a favorable linear pharmacokinetics (how drugs move within the body).
A Phase 2b study called CHANGE-MS (NCT02782858) is now recruiting participants with RRMS to evaluate the safety and movement of GNbAC1 and its effect on brain lesions shown on MRI scans. The study aims to examine the cumulative number of active brain lesions determined by MRI after six months of therapy, followed by additional MRI and clinical measures at 12 months.
The trial will enroll 260 participants at clinical sites throughout 13 European nations. The first results are expected by the end of 2017.
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