Roche’s investigational multiple sclerosis therapy ocrelizumab has smashed targets in two Phase III trials putting it on track for regulatory filing in the first quarter of next year.
While the Swiss drug giant hasn’t yet unveiled the data, it did reveal that in both OPERA studies the drug significantly reduced the annualised relapse rate of MS over a two-year period compared with interferon beta-1a.
The humanised monoclonal antibody also significantly cut the progression of clinical disability and the number of lesions in the brain (areas of disease activity) compared with interferon beta-1a.
Things also look good on the safety side, with Roche reporting that, overall, the incidence of adverse events linked with ocrelizumab was similar to interferon beta-1a; the most common adverse events being mild-to-moderate infusion-related reactions.
Commenting on the results, Sandra Horning, Roche’s 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, and “has the potential to make a meaningful difference for people with MS”.