Swiss healthcare giant Roche has reported striking new late-stage trial results for its multiple sclerosis–related therapy ENSPRYNG (satralizumab).

 

The results show a major reduction in disease relapses for patients with myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD).

 

The Phase III METEOROID study met its primary endpoint, with ENSPRYNG cutting the risk of a first relapse by 68% compared to placebo in adults and adolescents. 

 

The difference was statistically significant measured from randomisation to first relapse during the double-blind period.

 

“MOGAD is a rare autoimmune disease that can attack the optic nerves, brain and spinal cord and cause severe and unpredictable relapses, resulting in accumulating neurological damage, vision loss and disability. Currently, there are no approved treatment options for this debilitating disease” said Michael Levy, Associate Professor at Harvard School and Massachusetts General Hospital. 

 

“ENSPRYNG is the first medicine to show a meaningful clinical benefit for people with MOGAD in a pivotal trial, addressing the underlying neurological disability experienced by this patient population."

 

Roche said the results could mark a turning point in how the disease is treated.

 

“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,” said Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development. 

 

“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."

 

The data showed 87% of patients receiving ENSPRYNG remained relapse-free at 48 weeks versus 67% on placebo, with benefits emerging as early as eight weeks. The therapy also reduced annualised relapse rate by 66%, a key measure in a disease where each relapse can cause lasting neurological damage.