Genentech, Inc., a subsidiary of Roche Group (RHHBY.PK), and Biogen Idec (BIIB: Quote) Friday said a late-stage study of their investigational antibody ocrelizumab given in combination with methotrexate met primary endpoint of improving signs and symptoms in rheumatoid arthritis patients who had inadequate response to methotrexate.
Ocrelizumab is an investigational humanized anti CD20 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.
The multicenter, placebo controlled study in 1,015 patients consisted of a 48-week double-blind treatment period and study extension period of at least 48 weeks. Primary endpoint was to determine the proportion of patients with an American College of Rheumatology or ACR20 response at week 24 and week 48.
Genentech, however, said a higher percentage of serious infections was observed in the pooled ocrelizumab groups when compared to the placebo group, while safety analyses from the study are ongoing and will be presented at an upcoming medical meeting.
Rheumatoid arthritis is a debilitating autoimmune disease that affects around 1.3 million Americans. The damage that occurs in rheumatoid arthritis is a result of the immune system attacking joint tissue, causing painful chronic inflammation, irreversible destruction of cartilage, tendons and bones, which often results in disability.
The companies also said they will continue to analyze the study results and plan to submit the data for presentation at an upcoming medical meeting. Genentech noted that results of three other late stage studies investigating the use of ocrelizumab in rheumatoid arthritis are expected in the first half of 2010.
Commenting on the results, Hal Barron, M.D., executive vice president, Global Development and chief medical officer, Genentech, said, "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."
RHHBY.PK closed Thursday's regular trading at $41 per share.
BIIB closed Thursday's regular trading at 48.26 per share on the Nasdaq.
by RTT Staff Writer
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