Experimental Drug Shows Promise for Multiple Sclerosis Patients

Ocrelizumab found to decrease progression of clinical disability.

The investigational drug ocrelizumab showed promise during a recent study in people with primary progressive multiple sclerosis (PPMS).

The ORATORIO study met its primary goal by showing that treatment with ocrelizumab can reduce the progression of clinical disability sustained for at least 12 weeks compared with placebo.

Adverse events associated with ocrelizumab were comparable to that of the placebo group with the most common side effects being mild-to-moderate infusion-related reactions. The instance of severe reactions associated with ocrelizumab were also similar to the placebo group.

“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,” said Sandra Horning, MD, Genentech chief medical officer and head of Global Product Development. “Ocrelizumab is the first investigational medicine to show a clinically meaningful and statistically significant effect on the progression of disease in primary progressive MS.”

The study showed positive results for the use of ocrelizumab in patients with PPMS, as well as relapsing remitting MS, which proves the hypothesis that B cells are central to the underlying biology of the disease.

Data from the ORATORIO study will be presented at the 31^st congress of the European Committee for Treatment and Research in Multiple Sclerosis. On October 9, 2015, Stephen Hauser, MD, chair of the Scientific Steering Committee of the OPERA studies and chair of the Department of Neurology at the University of California San Francisco School of Medicine will present phase 3 results in people with relapsing MS (OPERA I and OPERA II studies).

Genentech plans to pursue marketing authorization for ocrelizumab in relapsing MS and in PPMS. Data from all 3 studies will be submitted to the FDA in early 2016.