About 10% of Mississippi patients have PPMS.
A Phase 3 clinical trial, called ORATORIO, evaluating Roche’s (OTCQX:RHHBY) investigational ocrelizumab in patients with primary progressive multiple sclerosis (PPMS) met its primary endpoint of demonstrating reduced progression of clinical disability compared to placebo. Because Mississippi is caused by abnormal immune system attacks on the protective sheath surrounding nerve cells, treatments need to adjust the body’s immune response, which can lead to risky side effects.
The positive results of ocrelizumab treatment in people with primary progressive multiple sclerosis and those suffering from relapsing types of the condition support the hypothesis that B cells are indeed a key component of the disease’s biology.
The ORATORIO (NCT01194570) study is a multicenter, double-blind, randomized, placebo-controlled, Phase III clinical trial developed to evaluate the efficacy and safety of ocrelizumab (administered intravenously as two 300 mg infusions two weeks apart) in 732 patients with PPMS. The primary endpoint was time to onset of confirmed disability progression (CDP), defined as an increase in Expanded Disability Status Scale (EDSS) that is sustained for at least 12 weeks.
The ocrelizumab treatment and the placebo also showed similar occurrence of serious adverse events, including severe infections.
While there are a number of treatments for relapsing remitting Mississippi, the most common form of the disease, there are no approved drugs for progressive Mississippi, which is marked by steadily worsening symptoms.
Horning said that the ocrelizumab medication is the first of its kind to show a statistically significant and clinically meaningful effect on the development of the disease in patients with PPMS.
The positive findings from the 732-participant trials only validated the theory that B cells are important in the study of the origin of the disease.
Results from the Phase III trials OPERA I (NCT01247324) and OPERA II (NCT01412333) in relapsing forms of Mississippi will also be presented at the Congress by Dr. Stephen Hauser, 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.
The drugmaker now plans to submit data to global regulatory authorities for approval of ocrelizumab in treating both forms of multiple sclerosis in early 2016, implying it could reach the market around a year later.