Genentech has announced that data from SAkuraSky, a pivotal Phase III study of the investigational medicine satralizumab for the treatment of neuromyelitis optica spectrum disorder (NMOSD), has been published in New England Journal of Medicine (NEJM).
People with NMOSD experience unpredictable, severe relapses that directly cause cumulative, permanent, neurological damage and disability. The condition is often misdiagnosed as multiple sclerosis. Satralizumab inhibits interleukin-6 (IL-6) signaling, which is believed to play a key role in the inflammation that occurs in people with NMOSD. Satralizumab can be self-administered every four weeks by subcutaneous injection.
“The positive results from the pivotal SAkuraSky study of satralizumab support the hypothesis that IL-6 plays a key role in NMOSD, which is a debilitating and potentially fatal condition,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “Satralizumab has shown robust efficacy sustained for 144 weeks across a broad patient population in two Phase III studies, whether given as a monotherapy or in combination with baseline therapy. We’re encouraged that satralizumab may soon provide a new treatment option for people living with NMOSD.”
SAkuraSky is a Phase III multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of satralizumab added to baseline immunosuppressant therapy in patients with NMOSD. The primary endpoint was the time to first relapse as adjudicated by an independent review committee in the double-blind period.
Detailed results published in NEJM highlight that in the overall study population, 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 in combination with baseline therapy.
“Among patients with NMOSD, satralizumab added to immunosuppressant treatment led to a lower risk of relapse than placebo but did not differ from placebo in its effect on pain or fatigue,” the published study concluded.
Overall, the proportion of patients with serious adverse events was similar between the satralizumab and placebo treatment groups. A lower rate of infections (including serious infections) was observed in patients treated with satralizumab compared with the placebo group. Most adverse events were mild to moderate, and the most common adverse events in the satralizumab group were upper respiratory tract infection, nasopharyngitis (common cold) and headache.
In October 2019, the U.S. Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) for satralizumab for the treatment of NMOSD. The FDA is expected to make a decision on approval in 2020.
See the full press release: https://www.gene.com/media/press-releases/14826/2019-12-01/positive-phase-iii-results-for-genentech