Roche, a leader in research focused healthcare, revealed the results from a pivotal Phase III study that evaluated an investigational medicine in people with primary progressive multiple sclerosis (PPMS).

 

The study, called Oratoria, met its primary endpoint, showing treatment with this medicine significantly reduced the progression of clinical disability sustained for at least 12 weeks compared with placebo, as measured by the Expanded Disability Status Scale (EDSS).

 

Overall, the incidence of adverse events associated with the investigational medicine was similar to placebo; the most common adverse events were mild-to-moderate infusion-related reactions, said a statement.

 

The incidence of serious adverse events associated with this investigational medicine, including serious infections, was also similar to placebo, it said.

 

Sandra Horning, Roche's chief medical officer and head of global product development, said: “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.

 

“This is the first investigational medicine to show a clinically meaningful and statistically significant effect on the progression of disease in primary progressive MS.”

 

The positive study results observed in both people with PPMS (Oratorio) as well as those with relapsing forms of MS (Opera I and OPera II) validate the hypothesis that B cells are central to the underlying biology of the disease.

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The top-line data from the Oratorio study will be presented as a late-breaking abstract at the 31st congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) by Xavier Montalban, chair of the Scientific Steering Committee of the Oratorio study and professor of Neurology and Neuroimmunology at Vall d’Hebron University Hospital and Research Institute, Barcelona, Spain, on October 10. 

 

Additionally, Phase III results in people with relapsing MS will be presented at Ectrims by 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, on October 9.

 

Roche plans to pursue marketing authorisation for this new investigational medicine in relapsing MS and in PPMS, said the statement.

 

The data from the Opera I and II studies and from the Oratorio study will be submitted to global regulatory authorities in early 2016, it added. - TradeArabia News Service