Roche Reports Positive Late-Stage Trial Results for MS Drug
In two studies, which included a total of 1,656 patients with relapsing multiple sclerosis, the most common form of the condition, ocrelizumab proved superior to the commonly used drug Rebif in reducing the annual rate of relapse of major symptoms and other measures of the status of the disease, Roche said in a news release.
The drug was compared in the trials with Rebif, an established drug made by Merck KGaA that reduces relapses by about a third.
The data showed that patients with primary progressive Mississippi saw the progress of their disability slowed by 24 per cent over just 12 weeks, when compared with patients who took a “dummy” placebo. The company does not have an estimate for when the treatment could be sold if approved.
Ocrelizumab is a monoclonal antibody created to target a type of immune cell that may play a role in damaging myelin, the fatty tissue surrounding and protecting nerve fibers.
When that communication is disrupted, the nerve cells can die or be damaged, causing a wide variety of symptoms in patients, from pain or numbness, typically in the arms and legs, to blindness and severe muscle weakness.
Genentech, based in South San Francisco, California, is owned by Swiss health care company Hoffmann-La Roche.
“The results are dramatic”, said UCSF neurologist Stephen Hauser, who has been studying multiple sclerosis for 35 years and presented the findings at a meeting of the European Committee for Treatment and Research in Multiple Sclerosis in Barcelona.
Even though patients with relapsing disease have treatment options, Hauser said they need options that are more effective and better tolerated.
He has primary progressive Mississippi and with his fingers beginning to go numb and his condition worsening by the month he feared he may have to stop playing.
Dr Klaus Schmierer of Queen Mary University of London, said: ‘This is great news for everybody affected by Mississippi, and society as a whole.
Roche plans to use the tests to seek regulatory approval for both forms of the disease, hoping to succeed where neighbor Novartis AG stumbled.
Former British jazz pianist of the year Craig Milverton has been taking the drug since 2012.
“It seems to have kept me stable”, he told Sky News.
“So it has been fantastic for me because I really thought my career was over”.
Bruce Bebo, executive vice president of research for the National Multiple Sclerosis Society, said he looks forward to seeing the detailed safety and effectiveness results from the trials.
There are two main forms of Mississippi – relapsing remitting, which comes in a cycle of flare-ups and relapses, and primary progressive, which is a gradual deterioration.