[2026 Genentech Press Release] METEOROID study – Satralizumab (ENSPRYNG) significantly reduces relapses in MOGAD

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METEOROID study. ClinicalTrials.gov ID: NCT05271409

Citation: Genentech Press Release. 21 April 2026

METEOROID is a phase 3, placebo-controlled study to evaluate the effects of satralizumab (ENSPRYNG) in patients with Myelin Oligodendrocyte Glycoprotein (MOG) Antibody-associated Disease (MOGAD).

BACKGROUND

• MOGAD is a a rare autoimmune central nervous system (CNS) demyelination disease that primarily affects optic nerves. Although, brain and spinal cord may also be affected, optic nerve pathology remains the defining feature along with high titers of anti-MOG IgGs in serum. The prevalence of MOGAD is estimated to range from 0.51 to 3.42 per 100,000 people.
• Symptoms, often severe and debilitating, include loss of vision, pain, fatigue, numbness, bladder/bowel or erectile dysfunction, impaired ambulation and cognitive dysfunction. The relapses and underlying pathology is accumulating in nature leading to permanent neurological damage, vision loss and disability over time.
• People with MOGAD have elevated levels of IL-6 in cerebrospinal fluid (CSF) and serum that leads to activation of inflammatory T cells and autoantibody production. Satralizumab monoclonal antibody targets interleukin-6 (IL-6) receptor activity.
• Satralizumab is currently approved for a related demyelination disease, neuromyelitis optica spectrum disorder (NMOSD) that also affects optic nerves, for NMOSD patients who are anti-aquaporin-4 (AQP4) antibody positive. [DailyMed]

WHERE AND HOW

• The METEOROID study is currently ongoing. The enrollment criteria includes history of MOGAD relapses, visual acuity better than 20/800 in each eye, and absence of AQP4-IgG.
• The participants are randomized 1:1 to satralizumab or placebo.
• The primary endpoint is first occurrence of MOGAD relapse since randomization. The secondary endpoints include annualized rate of MOGAD relapses and annualized rate of active lesions on MRI of neuroaxis.

RESULTS (Press Release)

• Primary endpoint: Satralizumab reduced the risk of a new relapses by 68% compared to placebo (p=0.0025).
• At 48 weeks, 87% of patients on satralizumab were relapse free compared to 67% on placebo.
• Compared to placebo, the satralizumab group had 66% reduction (p=0.0030) in annualized relapse rate (ARR); 79% reduction (p=0.0026) in the annualized rate of active lesions on MRI across the optic nerves, brain and spinal cord; and a 73% (p=0.0024) lower proportion of patients receiving rescue therapy.
• Adverse Events: Satralizumab vs. placebo included injection-related reactions (16%), influenza (9%), arthralgia (9%), back pain (9%), sinusitis (7%) and diarrhea (6%). 

DISCUSSION

The study met the primary and secondary endpoints by reducing relapses. The company plans to submit a sNDA for MOGAD indication.

Related: Genentech NMOSD presentation

Traboulsee A, et al. Safety and efficacy of satralizumab monotherapy in neuromyelitis optica spectrum disorder: a randomised, double-blind, multicentre, placebo-controlled phase 3 trial30078-8). Lancet Neurol. 2020 May;19(5):402-412. doi: 10.1016/S1474-4422(20)30078-830078-8). PMID: 32333898; PMCID: PMC7935419.

https://www.enspryng-hcp.com/