Roche Holding AG's Chugai Pharmaceutical Co. Ltd. said its drug satralizumab significantly reduced the relapse rate of a rare multiple sclerosis-like disease that is more prevalent in Asia.
Satralizumab outperformed the placebo as a standalone drug in a phase 3 clinical trial to treat neuromyelitis optica spectrum disorder, or NMOSD.
The trial dubbed SAkuraStar enrolled 90 patients aged between 18 and 74, and treated them with either 120 milligrams of satralizumab or placebo every two weeks. The study also tested patients' pain levels and fatigue as a secondary endpoint, though the company did not disclose those results in the news release.
NMOSD, also known as Devic's disease, is a rare neurological disorder that mostly affects the optic nerves and spinal cord, leading to symptoms including loss of vision, sensation and bladder function. The disease accounts for 10% to 60% of multiple sclerosis-like illnesses in Asia, according to the Mayo Clinic, although it affects only 1% to 3% of patients with the symptoms in North America. It has no approved treatment.
The drug works by prevents the signaling of the inflammatory cytokine IL-6, a protein that is believed to be a trigger for NMOSD.
In an earlier late-stage study for the drug, the Japan-based Roche subsidiary said the drug reduced relapse risk by 62% when combined with immunosuppressive therapy for patients with NMOSD.
Chugai said the same day that the U.S. Food and Drug Administration granted satralizumab a breakthrough therapy designation, which will help accelerate the approval process for the drug.
Alexion Pharmaceuticals Inc. said in September 2018 that its drug Soliris, or eculizumab, reduced the risk of a certain type of NMOSD relapse by 94.2% compared to placebo in a phase 3 study.