Roche reports Phase III METEOROID data showing ENSPRYNG® (satralizumab) reduced relapse risk by 68% in MOGAD patients, meeting primary endpoint.
Written By: Samiksha Jadhav, BPharm
Reviewed By: Pharmacally Editorial Team
Roche has reported positive Phase III results for ENSPRYNG® (satralizumab) in patients with myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD), a rare autoimmune disorder of the central nervous system for which no approved treatments currently exist.
Data from the METEOROID study (NCT05271409), presented at the 2026 American Academy of Neurology Annual Meeting, showed that satralizumab reduced the risk of relapse by 68% compared to placebo, meeting the primary endpoint of time to first relapse (p=0.0025). At 48 weeks, 87% of patients receiving satralizumab remained relapse-free versus 67% in the placebo group, with clinical benefit observed as early as eight weeks.
Secondary outcomes supported these findings, with a 66% reduction in annualised relapse rate (p=0.0030), a 79% decrease in active MRI lesion rates across the optic nerves, brain and spinal cord, and a 73% reduction in the use of rescue therapies such as steroids or immunoglobulins.
A numerical 17% reduction in hospitalisation rates was also observed, although this was not statistically significant. Treatment effects were consistent across patient subgroups, including age, sex, race and background therapy use.
The safety profile of satralizumab was consistent with prior data, with no new safety signals identified. Common adverse events included injection-related reactions, influenza, arthralgia, back pain, sinusitis and diarrhoea, while treatment interruption rates were low and similar between groups. One fatality occurred but was not considered related to treatment.
Michael Levy, MD, PhD, Associate Professor at Harvard School and Massachusetts General Hospital noted that MOGAD is a severe and unpredictable disease associated with recurrent attacks that can lead to cumulative neurological damage, vision loss and disability, and stated that satralizumab is the first therapy to demonstrate meaningful clinical benefit in a pivotal trial for this condition.
Levi Garraway M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development said the magnitude of relapse reduction seen in the study could help establish the first approved treatment for MOGAD and reflects the company’s focus on targeting underlying disease biology.
Satralizumab is a humanised monoclonal antibody targeting the interleukin-6 receptor, a pathway implicated in inflammation, autoantibody production and blood-brain barrier disruption in MOGAD.
The therapy is already approved in approximately 90 countries for AQP4-IgG seropositive neuromyelitis optica spectrum disorder and has been used in more than 9,000 patients.
Roche plans to submit the METEOROID data to regulatory authorities globally, while the therapy has also received orphan drug designation from the U.S. Food and Drug Administration for MOGAD and related neurological conditions.
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About the Writer
Samiksha Vikram Jadhav is a B.Pharm graduate with a strong academic foundation in pharmaceutical sciences, pharmacology, and drug development. She has a keen interest in healthcare advancements, clinical research, medical writing, and emerging therapies. Her work focuses on presenting developments in the pharmaceutical and healthcare sectors through clear and accurate scientific communication.