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Biogen drug shows remyelination potential


A new phase 2 RENEW study of anti-LINGO-1 in acute optic neuritis offers clinical results demonstrating the formation of new myelin on axons in MS patients. The study showed no effect on the secondary endpoint of neuroprotection.

The Phase 2 study involved 82 people who had their first incident of acute optic neuritis. The main finding of the study focused on a test that measures the visual system’s ability to conduct electrical signals between the retina and the brain. The results showed that people treated with the experimental drug and who did not miss more than one dose had significantly improved conduction as measured by the recovery of the time for a signal to travel from the retina to the brain’s visual cortex (latency) compared to people who received the placebo. At six months, those who received the drug improved by 34 percent. The effect continued to eight months with an average improvement of 41 percent. Additionally, the percentage of subjects whose visual evoked potential latency in the affected eye recovered to normal or nearly normal more than doubled.

“RENEW is the first study to show repair of the human central nervous system through remyelination, and the results support our ongoing development of this molecule,” said Alfred Sandrock, M.D., Ph.D., group senior vice president and chief medical officer at Biogen. “We believe the anti-LINGO-1 data point toward a potential new approach to treating demyelinating diseases, and we look forward to the ongoing Phase 2 SYNERGY study results to further clarify the potential of this investigational therapy in MS.”

Acute optic neuritis is a disease that typically affects one eye and is characterized by inflammation, damage to the nerve fibers and loss of myelin within the optic nerve.

The data will be presented at the 67th annual meeting of the American Academy of Neurology in Washington, D.C.

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