GlaxoSmithKline (NYSE:GSK) announces the start of its Phase 3 program evaluating otilimab, an anti-granulocyte macrophage colony-stimulating factor (anti-GM-CSF) monoclonal antibody, in patients with moderate-to-severe rheumatoid arthritis (RA) who have failed to respond adequately to disease-modifying antirheumatic drugs (DMARDs) or targeted therapies.
The program, called ContRAst, will include head-to-head comparisons with current treatments across all studies, including Pfizer’s (NYSE:PFE) XELJANZ (tofacitinib) Regeneron Pharmaceuticals (NASDAQ:REGN) and Sanofi’s (NASDAQ:SNY) KEVZARA (sarilumab).
The primary endpoint for the pivotal trials will be the proportion of patients achieving at least a 20% improvement in RA symptoms (ACR20).
GSK owns exclusive global rights to otilimab under a 2013 agreement with MorphoSys AG (NASDAQ:MOR).
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