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New RRMS Therapy to Be Tested

December 22, 2015

GeNeuro SA, a company that develops therapies for neurological and autoimmune disorders, announced the initiation of a Phase 2b clinical trial to assess its lead investigational antibody GNbAC1 in patients with relapsing-remitting multiple sclerosis (RRMS).

The trail is called CHANGE-MS and will involve 260 patients across 68 MS centers in Eastern Europe.

GNbAC1 is a humanised monoclonal antibody against the multiple sclerosis-associated retrovirus (MSRV)-Env. The MSRV-Env protein is pro-inflammatory and inhibits oligodendrocyte precursor cell differentiation (oligodendrocytes are the cells producing myelin, the protective sheath around neurons that is degraded in MS).

This phase 2b trial will be a randomized, double-blind, placebo-controlled and dose escalation study followed by a six-month open-label phase to test GNbAC1 in RRMS patients. The study aims to assess the clinical benefit of GNbAC1 in neutralizing the MSRV-Env protein, identified as a potential key factor fueling the inflammatory and neurodegenerative components of MS.