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Roche says its trial results validate the hypothesis that B lymphocytes are key targets in the mediation of the inflammatory damage characteristic of multiple sclerosis.
Roche announced positive Phase III results for its drug ocrelizumab on Sept. 28, 2015, saying that, compared with placebo, the investigational drug reduced the progression of clinical disability in primary-progressive multiple sclerosis (PPMS) over the course of 12 weeks. Clinical disability was measured by the Expanded Disability Status Scale (EDSS).
Ocrelizumab is touted as the “first investigational medicine to slow a clinically meaningful and statistically significant effect on the progression of disease in primary-progressive MS,” according to by Roche’s Chief Medical Officer and Head of Global Product Development Sandra Horning, MD, who made this statement in a press release. Moreover, Roche says the clinical trial data substantiate the claims that B cells are influential in MS pathogenesis, giving B-cell-directed therapeutic approaches validity. Many existing therapies, such as glatiramer acetate, decrease inflammation through mechanisms related to regulatory T cells, rather than B cells.
So far, no specific treatments have been shown to be effective for PPMS, which according to the National Multiple Sclerosis Society, is more difficult to diagnose and treat than relapsing forms of the disease. The current medications approved by FDA for the treatment of PPMS do not attack the underlying mechanisms of the disease; instead, the approved disease-modifying therapies tackle the symptoms of the disease and work primarily by reducing inflammation in the central nervous system (CNS).
Top-line data from the ORATORIO trial will be presented at the 31st congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), and Roche plans to submit these data to global regulatory authorities by early 2016.