Results – Now Published – from Phase 2 Myelin Repair Trial in Relapsing MS Help to Direct Future Studies Underway
July 9, 2019
Details of previously announced results have been published from a Phase 2 clinical trial of anti-LINGO (opicinumab), an experimental approach to repair myelin, the nerve-insulating coating damaged in multiple sclerosis. The trial, known as the SYNERGY study, did not meet its primary endpoint of improving measures of physical function (including walking, upper limb coordination), cognitive function, or disability. The trial involved 418 people with relapsing MS (including relapsing-remitting and secondary-progressive MS) who were taking interferon beta-1a (Avonex) plus one of several doses of intravenous opicinumab or inactive placebo for 72 weeks.
LINGO is a protein seen in neurons and myelin-producing cells (oligodendrocytes), and blockading this protein with opicinumab has been shown to promote myelin repair in animal models. Another Phase 2 clinical trial of opicinumab was positive. It involved people who had experienced optic neuritis, which is often the first clinical episode of MS.
Extensive testing and monitoring during the SYNERGY study were undertaken to pinpoint the patient population, dosage and outcome measures that would inform the design of future trials. After analyzing results, the team found better treatment responses among individuals who had MS for less than 20 years, and who had specific findings on two imaging techniques (magnetic transfer ratio and diffusion tensor imaging) which might indicate myelin damage with more intact nerve fibers.
Now, a new study is ongoing (finished recruiting), which has enrolled 263 participants with relapsing MS who experienced their first MS symptom within the past 20 years, and met the imaging criteria defined by evaluating data from the SYNERGY trial. The Phase 2 AFFINITY study
involves people who are using a disease-modifying therapy, plus either opicinumab or inactive placebo. The study is expected to be completed in 2022. Results will help to determine if opicinumab has potential for repairing damage and restoring function in people with MS.
Read a scientific summary of the SYNERGY study from The Lancet