Roche has announced data from its SAkuraSky study, in which the investigational medicine “satralizumab” – formerly SA237 - was evaluated for the treatment of neuromyelitis optica spectrum disorder (NMOSD); an inflammatory disorder of the central nervous system.
The results of the trial found that only eight of 41 patients (20%) treated with satralizumab in combination with baseline immunosuppressant therapy experienced a protocol-defined relapse (PDR), compared to 18 of 42 patients (43%) treated with placebo.
Further to these findings, 89%, 78% and 74% of patients on satralizumab in combination with baseline therapy were relapse-free at weeks 48, 96 and 144 compared to 66%, 59% and 49% with placebo in combination with baseline therapy.
In addition, In the AQP4-IgG seropositive subgroup analysis - a group of patients that experience a more severe disease course - three of 27 patients (11%) treated with satralizumab experienced a PDR compared to 12 of 28 patients (43%) treated with placebo
Overall, the proportion of patients with serious adverse events was similar between the satralizumab and placebo treatment groups and a lower rate of infections (including serious infections) was observed in patients treated with the drug compared with the placebo group.
The drug, which works by targeting the interleukin-6 (IL-6) receptor, a potential key driver of neuromyelitis optica spectrum disorder, was administered subcutaneously at week zero, two, and four, and then continued at four-week intervals.
It has been designated as an orphan drug in the US, Europe and Japan as well as being granted Breakthrough Therapy Designation for the treatment of NMOSD by the FDA in December 2018.
The positive results support the idea that “IL-6 plays a key role in NMOSD, which is a debilitating and potentially fatal condition,” said Levi Garraway, Roche’s chief medical officer and head of global product development.
He also mentioned that the company is “encouraged that satralizumab may soon provide a new treatment option for people living with NMOSD.”
People with NMOSD experience unpredictable, severe relapses that directly cause cumulative, permanent, neurological damage and disability. The condition is often misdiagnosed as multiple sclerosis.