Roche’s satralizumab succeeds in second positive study in rare CNS disease
pharmafile | September 12, 2019 | News story | Research and Development | NMOSD, Roche, satralizumab
In a second pivotal Phase 3 study of Roche’s satralizumab, the drug showed itself to significantly reduce relapse risk for neuromyelitis optica spectrum disorder (NMOSD), a rare central nervous system disease.
NMOSD is a rare, lifelong and debilitating autoimmune disease of the central nervous system that primarily damages the optic nerves and spinal cord, causing blindness, muscle weakness and paralysis.
Individuals with NMOSD often experience unpredictable severe relapses directly causing cumulative, permanent, neurological damage and disability. It currently affects over 10,000 people in Europe and 15,000 in the US.
Satralizumab inhibits IL-6 signalling, which is believed to play a key role in the inflammation that occurs in people with NMOSD leading to disability.
In the study, called SAkuraStar, monotherapy achieved a 55% reduction in risk of relapses compared to placebo. In the overall satralizumab-treated population, 76.1% were relapse-free at 48 weeks and 72.1% relapse-free at 96 weeks compared to 61.9% and 51.2% with placebo respectively.
Data from the AQPr-IgG seropositive subgroup was even more positive as 82.9% were relapse-free at 48 weeks and 76.5% at 96 weeks compared with to 55.4% and 41.1% of those on placebo.
Sandra Horning, Chief Medical Officer and Head of Global Product Development at Roche, said: “While first described 125 years ago, the underlying biology of NMOSD has only recently been understood. The positive results from the pivotal SAkuraStar and SAkuraSky studies support the hypothesis that IL-6 plays a key role in this devastating disease that can take away people’s independence.
“We are encouraged by these results and look forward to working with regulators over the coming months to bring satralizumab to people living with NMOSD as soon as possible.”
Nik Kiran
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