Using the same measures, there was also no evidence of a slowdown in disability progression. However, there were indications of a clinical effect and the company will continue with a detailed analysis of the data in order to plan further studies.
The clinical trial (called SYNERGY) was designed to test whether opicinumab could improve disability. The phase II trial involved 418 participants with relapsing remitting or secondary progressive MS who took Avonex (interferon beta 1a) once a week in combination with different doses of opicinumab or placebo by intravenous infusion every 4 weeks for 72 weeks. Disability was monitored using a combination of measures of walking ability, arm and hand dexterity, cognition and EDSS.
Results from another clinical trial of opicinumab, RENEW, were more positive. In this phase II clinical trial opicinumab was compared to placebo in 82 people who’d recently had a first episode of optic neuritis (but did not have MS). Opicinumab was no better than placebo at improving vision, but the time for a signal to travel from the retina of the eye to the brain (measured by visual evoked potentials) was improved slightly but statistically significantly in those who took opicinumab – possible evidence that the myelin sheath around the optic nerve had been repaired.