GSK Launches Phase III ContRAst Program for Anti-GM-CSF Monoclonal Antibody Otilimab in Rheumatoid Arthritis

July 04, 2019/BioValleyBIOON/--UK pharmaceutical giantGlaxoSmithKline(GSK) recently announced the launch of ContRAst, a Phase III clinical development program for the antibody drug otilimab. This investigational anti-granulocyte-macrophage colony-stimulating factor (anti-GM-CSF) monoclonal antibody is being developed for the treatment of moderate to severe rheumatoid arthritis in patients with an inadequate response to disease-modifying antirheumatic drugs (DMARDs) or targeted therapies.Rheumatoid Arthritis(RA) patients. The initiation of this project is based on the results of the Phase II BAROQUE study announced in October 2018.

Dr. Hal Barron, Chief Scientific Officer and President of Research and Development at GSK, stated: “Our Phase II study data demonstrate encouraging clinical benefits of otilimab in patients with rheumatoid arthritis (RA). This unique Phase III program, designed in consultation with regulatory authorities, will help us understand how this potential new medicine may benefit patients with RA.”

ContRAst is the first Phase III clinical program in the rheumatoid arthritis (RA) field to conduct head-to-head comparisons of otilimab with current therapies across all pivotal studies. The program compares otilimab with two agents having distinct mechanisms of action: tofacitinib (a JAK inhibitor) and sarilumab (an anti-IL-6 monoclonal antibody). It will enroll a broad population of refractory patients who have had an inadequate response to or are intolerant of currently available therapies. The program comprises three pivotal Phase III studies (contRAst-1, -2, and -3) and one long-term extension study (contRAst-X). The primary endpoint of the pivotal studies is the proportion of patients achieving the American College of Rheumatology 20% improvement criteria (ACR20) at Week 12, compared with placebo.

ClassRheumatoid Arthritis(Rheumatoid arthritis (RA)) is a chronic systemic inflammatory disease characterized by pain, joint swelling, stiffness, joint destruction, and disability. The disease affects 24.5 million people worldwide. Despite the use of disease-modifying antirheumatic drugs (DMARDs), a significant proportion of patients remain non-responsive or exhibit an inadequate response. Therefore, there is a need for more effective therapeutic agents with distinct mechanisms of action.

otilimab (formerly GSK3196165) is a fully human monoclonal antibody that inhibits granulocyte-macrophage colony-stimulating factor (GM-CSF), a cytokine involved in a broad range of immune-mediated diseases, includingRheumatoid Arthritis) protein that plays a central role. GM-CSF acts on cells, including macrophages (a type of immune cell that plays a key role in the inflammatory process), leading to inflammation, joint damage, and pain. Otilimab neutralizes the biological function of GM-CSF by blocking its interaction with cell surface receptors.

In 2013, GSK obtained the exclusive global rights to develop and commercialize otilimab across all therapeutic areas from MorphoSys AG. (Bioon.com)

Original source:GSK announces phase III start for its anti GM-CSF antibody, otilimab, in patients with rheumatoid arthritis (RA)