Roche’s ocrelizumab has shown significant efficacy in treating primary progressive multiple sclerosis in a large phase III study.
The new data marks ocrelizumab out as the first investigational medicine to show positive study results in both primary progressive and relapsing forms of multiple sclerosis.
The study, called ORATORIO, met its primary endpoint, highlighting that treatment with ocrelizumab significantly reduced the progression of clinical disability sustained for at least 12 weeks compared with placebo as measured by the Expanded Disability Status Scale (EDSS).
Sandra Horning, CMO at Roche and head of global product development, said: “People with the primary progressive form of MS typically experience symptoms that continuously worsen after the onset of their disease, and there are no approved treatments for this debilitating condition.
“Ocrelizumab is the first investigational medicine to show a clinically meaningful and statistically significant effect on the progression of disease in primary progressive MS.”
Pharmaceutical companies have struggled in developing treatments for MS and earlier this year Sanofi company Genzyme entered into a research collaboration with Ablynx to investigate treatments for the condition.
Ocrelizumab is a humanised monoclonal antibody designed to selectively target CD20-positive B cells which are an immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage.
The results from the study validate the hypothesis that B cells are central to the underlying biology of the disease.The new data comes a few months after ocrelizumab outperformed interferon beta therapy in two-phase III trials.
Analysts have previously suggested ocrelizumab could eventually become the treatment of choice in MS patients whose disease is continuing to advance despite treatment with first-line therapies.
Roche plans to submit an application for ocrelizumab in early 2016 for global regulatory approval in both primary progressive MS and relapsing MS.