Roche announced data from a mid-stage trial demonstrating that ocrelizumab, which the drugmaker is developing in partnership with Biogen Idec, significantly reduced disease activity in patients with relapsing-remitting multiple sclerosis (RRMS). "These efficacy results are amongst the most remarkable seen in a Phase II study," commented lead investigator Ludwig Kappos.
The 24-week trial randomised 220 patients to receive one of two doses of ocrelizumab or placebo given at day one and day 15. Data show that the highest and lowest dose of the experimental drug reduced the total number of brain lesions detected by magnetic resonance imaging by 96 percent and 89 percent, respectively, compared to placebo. In addition, disease activity, or annualised relapse rates, was reduced by 73 percent among patients receiving the highest dose of the drug and by 80 percent in patients receiving the lower dose.
Commenting on the study results, Vontobel analyst Andrew Weiss said that "the data still lacks a few missing pieces, but if it is what it looks like ... ocrelizumab has a ... strong efficacy profile, especially in relapse rates. In May, the companies announced plans to halt development of the drug in patients with rheumatoid arthritis due to an unfavourable risk profile, prompting concerns that it could be discontinued in other indications
Reference Articles
Roche shares jump on positive multiple sclerosis drug data (free preview) - (NASDAQ)
Phase II study with ocrelizumab shows significant reduction in disease activity for multiple sclerosis patients - (Roche)
Genentech, Biogen report 24-week Phase II study results of ocrelizumab - (Stock Markets Review)
Roche: Study shows ocrelizumab reduces MS disease activity (free preview) - (The Wall Street Journal)
**Published in "First Word"
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