Drug Successfully Restores Myelin in Phase 2 Trial
MARCH 26, 2015
A Phase 2 acute optic neuritis (AON) trial has met its primary efficacy endpoints which included medication that restores myelin, according to information released by Biogen Idec.
Researchers determined that anti LINGO 1, the medication tested to restore myelin, could help repair the damaged visual system for patients. Anti LINGO 1 was tested in the RENEW trial, which is part of a larger Biogen Idec trial for multiple sclerosis (MS) patients. The study examined effects on remyelination in 82 patients in 33 European sites by measuring the latency of nerve conduction between the retina and the visual cortex in the brain using full field visual evoked potential (FF VEP) for a period of 24 weeks. The patients received 6 intravenous infusions of 100 mg/ kg anti LINGO 1 or placebo once every 4 weeks. The larger SYNERGY trial should produce results in 2016, the company expects.
Anti LINGO 1 showed improvement in the recovery of optic nerve latency when measured by FF VEP, which is the time for a signal to travel from the retina to the visual cortex, when compared to a placebo group. The researchers from the study also noted there was no effect on secondary endpoints – including change in thickness of the retinal layers, visual function, and low contrast letter acuity.
There was a 34 percent improvement in the recovery of the optic nerve latency when compared to placebo in the per protocol population. In the intent to treat (ITT) group, there was a positive trend but the researchers wrote that it was not statistically significant.
“We believe the RENEW results are encouraging, as this is the first clinical trial to provide evidence of biological repair in the central nervous system (CNS) by facilitating remyelination following an acute inflammatory injury,” Alfred Sandrock, MD, PhD, group senior vice president and chief medical officer at Biogen Idec, said in a press release. “We look forward to the SYNERGY results in 2016 to further advance our understanding of this molecule in MS, including a full dose response. The totality of the data from the two Phase 2 studies may provide us with a clearer understanding of anti LINGO 1’s clinical potential.”
There were not many adverse effects and the drug was overall well tolerated. Two patients experienced hypersensitivity reactions categorized as serious adverse events, and there were no deaths.