An experimental drug has performed well in three pivotal Phase III studies in the treatment of relapsing multiple sclerosis and primary progressive multiple sclerosis patients, announced the drug’s manufacturer, California-based Genentech. The biotech corporation is a subsidiary of Swiss-based Roche Holding AG.
The results, presented at last month’s Congress of the European Committee for Treatment and Research in Multiple Sclerosis, suggest the Investigational drug ocrelizumab may offer treatment for progressive forms of the disease.
Multiple sclerosis (MS) is an unpredictable, often disabling disease of the central nervous system that disrupts the flow of information within the brain, and between the brain and body, according to the National Multiple Sclerosis Society. More than 2.3 million people are affected by MS worldwide.
The disease is progressive and has no cure, reports Patricio Inacio, Ph.D. The most common type of MS is relapsing multiple sclerosis, which affects about 85% of all patients who have the disease. She also notes that “Primary progressive MS (PPMS) is characterized by escalating worsening symptoms and affects 1 in every 10 MS patients. No approved treatments currently exist for (it).” Also, PPMS typically worsens without distinct relapses or periods of remission.
"Ocrelizumab is the first investigational medicine to significantly reduce disability progression in people with relapsing MS and people with (PPMS)," said Dr. Sandra Horning, Roche's chief medical officer and head of global product development.
Data from two identical studies (called OPERA I and OPERA II) in people with relapsing MS showed ocrelizumab was superior to interferon beta-1a , a well-established MS therapy, in reducing the three major markers of disease activity over the two-year controlled treatment period.
In a separate study (called ORATORIO) in people with PPMS, the drug significantly reduced the progression of clinical disability sustained for at least 12 weeks and 24 weeks compared with placebo.
“These results redefine our understanding of MS by highlighting the central role of the B cell,” said Stephen Hauser, M.D., chair of the scientific steering committee of the OPERA studies. “The findings may also encourage the MS community to look more closely at earlier treatment of the disease. Currently, many doctors reserve what are considered highly effective MS medicines until a patient’s disease becomes more advanced. Patients and their doctors need new treatment options that offer the potential for greater efficacy than a standard-of-care interferon with a similar safety profile.”
Daniel O’Day, Roche’s head of pharmaceuticals, said the drug maker plans to file for approval in the U.S. and Europe in the first half of 2016.