Roche's ENSPRYNG cuts MOGAD relapse risk by 68%
- Phase III METEOROID: Roche's satralizumab (ENSPRYNG) reduced risk of first MOGAD relapse by 68% versus placebo (p=0.0025), with 87% relapse-free at 48 weeks versus 67% on placebo.
- Secondary outcomes: annualised relapse rate decreased 66% (p=0.0030); MRI-active lesions fell 79% (p=0.0026); rescue therapy use dropped 73% (p=0.0024).
- Randomised double-blind placebo-controlled trial in patients ≥12 years, weight-based subcutaneous dosing (60/120/180 mg) at 0,2,4 weeks then every 4 weeks; double-blind period ended after 28 adjudicated relapses and data will be filed with regulators.
METEOROID primary results
Phase III METEOROID showed satralizumab (ENSPRYNG) reduced risk of first MOGAD relapse by 68% versus placebo (p=0.0025); 87% of treated patients were relapse-free vs 67% on placebo at 48 weeks, with onset of effect by week 8.
Secondary outcomes
Annualised relapse rate fell 66% (p=0.0030); MRI-active lesions across optic nerves, brain and spinal cord decreased 79% (p=0.0026); use of rescue therapies dropped 73% (p=0.0024); inpatient hospitalisations fell 17% (p=0.7528).
Safety
No new safety signals; adverse events ≥5% with satralizumab included injection-related reactions 16%, influenza 9%, arthralgia 9%, back pain 9%, sinusitis 7% and diarrhoea 6%; AE-related temporary treatment interruptions were 6% with satralizumab and 5% with placebo; one fatality was judged unrelated to treatment.
Study design, mechanism and next steps
Randomised, double-blind, placebo-controlled trial in participants ≥12 years, 1:1 randomisation with weight-based subcutaneous dosing (60/120/180 mg) at 0, 2 and 4 weeks then every 4 weeks; background immunosuppressants were permitted; the double-blind period ended after 28 adjudicated relapses and an open-label extension is available; satralizumab targets the IL-6 receptor to reduce CNS inflammation and antibody production; METEOROID data were presented at AAN 2026 and will be submitted to regulators.
Source: Roche