Roche has reported new findings from the Phase III METEOROID trial of Enspryng (satralizumab) in adults and adolescents with myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD).
The double-blind, randomised, multi-centre, placebo-controlled trial revealed that Enspryng reduced the risk of a new relapse by 68% against placebo, meeting the primary endpoint.
MOGAD is a rare autoimmune condition of the central nervous system (CNS) that primarily affects the optic nerves, but may also impact the brain and spinal cord.
At 48 weeks, 87% of patients on Enspryng remained relapse-free, compared with 67% on placebo. The onset of response was seen within eight weeks.
A consistent treatment effect was reported across subgroups, including age, sex, race and background therapy use.
Enspryng also reduced the annualised relapse rate (ARR) by 66%, a key secondary endpoint.
Other significant secondary endpoints showed Enspryng reduced central nervous system (CNS) inflammation and decreased the use of rescue treatments such as steroids, plasma exchange or intravenous immunoglobulins.
A 79% reduction in the annualised rate of active MRI lesions and a 73% lower proportion of patients requiring rescue therapy were reported compared to placebo.
Additionally, a 17% reduction in annualised inpatient hospitalisation rate was observed with Enspryng.
No new safety concerns were identified. Enspryng’s safety profile was consistent with previous clinical and post-approval datasets in the aquaporin-4 immunoglobulin (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD) population.
Common adverse events included arthralgia, back pain, diarrhoea, influenza, injection-related reactions, and sinusitis.
The trial involved adults and adolescents aged 12 years and above with MOGAD, utilising subcutaneous administration and offering an open-label extension after the double-blind period.
Roche chief medical officer and head of global product development Levi Garraway said: “The remarkable 68% reduction in relapses seen in the METEOROID study has the potential to redefine the standard of care and to deliver the first and only approved treatment for this debilitating rare disease.
“This milestone represents a breakthrough for the MOGAD community, and reinforces our commitment to developing new treatments that address the underlying biology of challenging neurological conditions.”
Last month, Roche reported that the pivotal Phase III FENhance 1 trial of its investigational Bruton’s tyrosine kinase (BTK) inhibitor, fenebrutinib, in relapsing multiple sclerosis (RMS), achieved the primary endpoint.
