Positive results from two Phase III studies on the compound ocrelizumab were announced today by Genentech. Ocrelizumab was shown to significantly reduce multiple sclerosis relapses and disability progression versus interferon beta-1a in the OPERA I and OPERA II studies.
Ocrelizumab is a product of the company Genentech, which is a member of the Roche Group.
Sandra Horning, M.D., chief medical officer and head of Global Product Development, said:
“Ocrelizumab showed remarkable improvements over a standard-of-care medicine across clinical and imaging endpoints in two pivotal studies. Ocrelizumab has the potential to make a meaningful difference for people with MS, a chronic and debilitating disease. Based on these compelling results, we plan to submit the data for review to U.S. and EU regulatory authorities in the first quarter of 2016.”
Treatment with ocrelizumab also led to a significant reduction in the number of lesions in the brain, areas of disease activity, compared with interferon beta-1a, as observed by MRI scans.
Multiple sclerosis, also known as disseminated sclerosis or encephalomyelitis disseminata, is an inflammatory disease in which the insulating covers of nerve cells in the brain and spinal cord are damaged. This damage disrupts the ability of parts of the nervous system to communicate, resulting in a wide range of signs and symptoms, including physical, mental, and sometimes psychiatric problems.
Analyses of the data from the OPERA studies is ongoing. Genetech is planning to present detailed data at an upcoming medical congress.
Additionally, the results from a Phase III study of ocrelizumab in people with primary progressive MS (PPMS), a distinct form of MS, are expected later this year.
Ocrelizumab is an investigational monoclonal antibody. It is designed to selectively target CD20-positive B cells.
CD20-positive B cells are a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage, which can result in disability in people with MS.
Ocrelizumab binds to CD20 cell surface proteins expressed on certain B cells, but not on stem cells or plasma cells. Therefore the ability to make new B cells is preserved in people treated with ocrelizumab.
Image: Asuka Eguchi, UW-Madison