Roche (OTCQX:RHHBY) unit Genentech announces positive results from a Phase 3 clinical trial, SAkuraStar, evaluating satralizumab as monotherapy in patients with a rare debilitating central nervous system disease called neuromyelitis optica spectrum disorder (NMOSD) that is frequently misdiagnosed as multiple sclerosis. The data were presented at ECTRIMS in Stockholm.
Treated patients experienced a 55% reduction in the risk of relapses compared to placebo, which was 74% in a subgroup of subjects seropositive for AQP4-IgG antibodies (these patients typically experience more severe disease).
76.1% of patients in the treatment group were relapse-free at week 48 while 72.1% were relapse-free at week 96 versus 61.9% and 51.2%, respectively, in the control group. The rates in the AQP4-IgG subgroup were 82.9% and 76.5%, respectively, compared to 55.4% and 41.1%, respectively, for placebo.
Results from another Phase 3, SAkuraSky, evaluating satralizumab as add-on therapy to immunosuppressive treatment in NMOSD (and neuromyelitis optica) also demonstrated a significant treatment benefit.
Satralizumab is a humanized monoclonal antibody that dampens the activity of proinflammatory interleukin 6 (IL-6) by binding to its receptor. IL-6 is believed to be a key driver of NMOSD.
Regulatory filings are next up.
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