Roche, Genentech, Inc a wholly owned member of the Roche Group, and Biogen Idec announced a phase-III study (STAGE) of the investigational humanized anti-CD20 monoclonal antibody ocrelizumab given in combination with methotrexate (MTX) met its primary endpoint of improving signs and symptoms (as measured by American College of Rheumatology or ACR20 response) in rheumatoid arthritis (RA) patients who had an inadequate response to MTX at both 24 and 48 weeks. The companies continue to analyze the study results and plan to submit the data for presentation at an upcoming medical meeting.
“These results are significant because they are the first data from a large phase-III trial to show that a humanized antibody targeted at B-cells improves the signs and symptoms of rheumatoid arthritis,” said Hal Barron, executive vice president,
Global Development and chief medical officer, Genentech. “These results build on earlier findings from our broad clinical program aimed at developing medicines to help people living with rheumatoid arthritis.”
“Patients living with a debilitating disease like rheumatoid arthritis can benefit from additional treatment options. We look forward to seeing the results of our ongoing phase-III rheumatoid arthritis trials with ocrelizumab,” aid David Hagerty, vice president and chief medical officer, Rheumatology, Biogen Idec.
Ocrelizumab is an investigational humanized monoclonal antibody that selectively binds to a particular protein - the CD20 antigen - on the surface of B-cells, which are believed to play a critical role in immunologic diseases.
Founded more than 30 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes biotherapeutics to treat patients with serious or life-threatening medical conditions.
Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the discovery, development, manufacturing and commercialization of innovative therapies.