Background
Pharmaceutical company Biogen Idec announced results from a phase II clinical trial assessing the safety and efficacy of potential MS drug anti-LINGO-1 in individuals affected by acute optic neuritis (AON). Optic neuritis is one of the first symptoms experienced by an estimated 16% of people with MS and can commonly occur during the course of disease. In August of last year the MS Society reported on the results of a phase I clinical trial of anti-LINGO-1, which was designed to establish the safety profile of the drug at various doses in people with MS. Results of the phase I trial showed a stable safety profile among 47 individuals with MS and 72 healthy volunteers, which led to a phase II clinical program involving two studies called RENEW and SYNERGY. The first to be completed was RENEW, which studied the ability for anti-LINGO-1 to stimulate repair of myelin around the optic nerve. Researchers reported that treatment with anti-LINGO-1 showed evidence of biological repair of the visual system compared to placebo.
The Study
RENEW was a randomized, double-blind, placebo-controlled phase II clinical trial evaluating the effect of anti-LINGO-1 in patients treated following a first episode of AON. The study enrolled 82 volunteers across 33 sites in Europe, Canada and Australia, who were selected to receive either a total of 6 intravenous infusions of anti-LINGO-1 or a placebo every four weeks.
Results
Results of the RENEW trial showed a 34% improvement in optic nerve performance following treatment, as determined by measuring the time for a signal to travel from the retina to the visual cortex, relative to placebo. Although the outcome offered “proof-of-biology” evidence, the outcome did not reach statistical significance. The study showed no effect on secondary endpoints, including change in thickness of the retinal layers (optic nerve neurons and axons) and visual function.
The second part of the phase II clinical program, SYNERGY, is currently ongoing and focuses more on MS. The phase II, dose-range finding, randomized, double-blind, placebo-controlled 22-month study is fully enrolled, and results are anticipated in 2016.
Comment
The impact of anti-LINGO-1 on visual function speaks to its potential in repair of other areas of the central nervous system, all of which are affected by MS. Although the data did not reach statistical significance, the study is encouraging as it demonstrates remyelination capabilities of this novel treatment and potential to treat one of the more common symptoms of MS – optic neuritis – which can be very disruptive and painful for people living with MS. Further research is needed, however, to affirm these findings and uncover the full potential for anti-LINGO-1 to stimulate repair and neuroprotection. The MS Society will continue to provide updates on this and other similar clinical trials as information becomes available. To learn about MS treatments in the pipeline, visit the MS Society Treatments in Development page.