Conference Coverage
WASHINGTON, DC—A new study suggests that an investigational drug for multiple sclerosis (MS) may repair myelin, according to a study presented at the American Academy of Neurology’s 67th Annual Meeting. “This study, for the first time, provides biological evidence of repair of damaged myelin in the human brain and advances the field of neuroreparative therapies,” said study lead author Diego Cadavid, MD, a Senior Director at Biogen Idec in Cambridge, Massachusetts.
The phase 2 study involved 82 patients who had their first incident of acute optic neuritis. All participants were treated with high dose steroids and randomly selected with equal probability to receive either the experimental antibody, called anti-LINGO-1, or a placebo once every four weeks, for a total of six doses. Participants were assessed every four weeks for six months and at a final visit at eight months. The drug’s effectiveness in repairing myelin was evaluated by comparing the recovery of the optic nerve latency in the damaged eye at six and eight months to the normal unaffected eye at the start of the study.
The main finding of the study focused on the latency of the visual evoked potential (VEP). The results showed that patients treated with anti-LINGO-1 who did not miss more than one dose (per protocol population) had significantly improved conduction, as measured by latency recovery, compared with people who received the placebo. At six months, those who received the drug improved on average by 7.55 milliseconds, or 34%, compared with placebo. The effect continued to eight months with an average improvement of 9.13 milliseconds or 41% over placebo.
In addition, the percentage of subjects whose VEP latency in the affected eye recovered to normal or nearly normal (ie, within 10% of that of the normal eye) more than doubled from 26% on placebo to 53% on the drug.
A substudy using an exploratory method of measuring latency called multifocal VEP revealed similar treatment effects. “More studies are needed to evaluate whether these changes lead to clinical improvement,” said Dr. Cadavid. A second study of anti-LINGO-1 in patients with MS is ongoing.
The study was supported by Biogen Idec.