Enspryng Reduced Relapse Risk for MOGAD in Phase 3 Trial
KEY TAKEAWAYS
- Satralizumab treatment reduced risk of relapse by 68% vs placebo in people with MOGAD.
- Most treated patients remained relapse-free at 1 year.
Treatment with Enspryng (satralizumab; Genentech, South San Francisco, CA) significantly reduced relapse risk in individuals with myelin oligodendrocyte glycoprotein antibody–associated disease (MOGAD), according to new results from the phase 3 METEOROID trial (NCT05271409) presented at the 2026 American Academy of Neurology (AAN) Annual Meeting. Enspryng was previously approved by the Food and Drug Administration (FDA) in 2020 for the treatment of anti-aquaporin–4 antibody positive (AQP4+) neuromyelitis optical spectrum disorder (NMOSD), but there are currently no medications approved for the treatment of individuals with the rare autoimmune disorder MOGAD.
In the randomized, double-blind, placebo-controlled, multicenter study, adult and adolescent participants aged 12 years and older with MOGAD were randomized 1:1 to receive subcutaneous treatment with Enspryng (60 mg, 120 mg, or 180 mg based on body weight) or placebo at weeks 0, 2, and 4, and then every 4 weeks thereafter. Participants were permitted to continue background immunosuppressive therapy. The primary end point was time to first adjudicated relapse during the double-blind period.
Key Findings
- Enspryng reduced the risk of relapse by 68% compared with placebo (P=.0025), meeting the primary end point.
- At 48 weeks, 87% of patients receiving Enspryng were relapse-free compared with 67% in the placebo group.
- Annualized relapse rate was reduced by 66% with Enspryng vs placebo (P=.0030).
- MRI activity was reduced, with a 79% decrease in the annualized rate of active lesions, and fewer patients required rescue therapies (73% reduction vs placebo).
- Adverse events were consistent with the known safety profile; no new safety signals were identified.
Treatment-emergent adverse events occurred at similar rates between groups, and serious adverse events were not considered treatment related.
Source
Genentech. Genentech’s Enspryng (satralizumab) reduces risk of relapses by 68% demonstrating potential to become first treatment for MOGAD. Published April 21, 2026. Accessed April 23, 2026. https://www.gene.com/media/press-releases/15108/2026-04-21/genentechs-enspryng-satralizumab-reduces