Genetech says Phase III METEROID study of Enspryng meets primary endpoint

Genentech announced new data from the Phase III METEOROID study demonstrating that Enspryng reduced the risk of a new relapse by 68% compared to placebo in adults and adolescents with myelin oligodendrocyte glycoprotein antibody-associated disease, meeting its primary endpoint. The primary endpoint was measured by the time from randomization to the first MOGAD relapse during the double-blind treatment period. The results were shared at a late-breaking oral presentation in the Clinical Trials Plenary Session at the 2026 American Academy of Neurology Annual Meeting in Chicago. The primary endpoint showed 87% of patients on Enspryng were relapse free compared to 67% on placebo at 48 weeks, with onset of response observed as early as 8 weeks. A generally consistent treatment effect was observed across subgroups, including age, sex, race and background therapy use. Enspryng also reduced the annualized relapse rate by 66%, a key secondary endpoint, as disability in MOGAD is related to acute relapses, and treatment aims to prevent subsequent relapses. Other key secondary endpoints that were statistically significant showed Enspryng has the potential to reduce central nervous system inflammation and use of rescue therapies such as steroids, plasma exchange or intravenous immunoglobulins. With Enspryng, there was a 79% reduction in the annualized rate of active lesions on MRI across the optic nerves, brain and spinal cord and a 73% lower proportion of patients receiving rescue therapy compared to placebo. In addition, a numerical 17% reduction in the annualized rate of inpatient hospitalizations was observed with Enspryng compared to placebo. No new safety signals were reported with Enspryng, and the safety profile was consistent with established data from more than a decade of Enspryng clinical trial and post-approval experience in aquaporin-4 immunoglobulin seropositive neuromyelitis optica spectrum disorder. Adverse events greater than or equal to5% and more commonly observed in patients receiving Enspryng vs. placebo included injection-related reactions, influenza, arthralgia, back pain, sinusitis and diarrhea. There were low rates of AEs leading to temporary treatment interruption with Enspryng and placebo. There was one fatality not related to treatment, and none of the serious AEs were considered related to treatment. The METEOROID data will be submitted to regulatory authorities globally.