A new study suggests that an investigational drug for multiple
sclerosis (MS) may repair myelin, the fatty material that protects
nerves and is damaged in MS, according to a study released today that
will be presented at the American Academy of Neurology’s 67th Annual
Meeting in Washington, DC, April 18 to 25, 2015.
“This study, for
the first time, provides biological evidence of repair of damaged
myelin in the human brain, and advances the field of neuro-reparative
therapies,” said study lead author Diego Cadavid, MD, with Biogen in
Cambridge, Mass., and a fellow with the American Academy of Neurology.
Phase 2 study involved 82 people who had their first incident of acute
optic neuritis, 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. It is estimated that about half of people
with optic neuritis will later develop multiple sclerosis.
participants were treated with high dose steroids and then 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 then assessed every four weeks
for six months and 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.
main finding of the study focused on the latency of the visual evoked
potential (VEP), 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 (per protocol population) had significantly
improved conduction as measured by latency recovery compared to people
who received the placebo. At six months, those who received the drug
improved on average by 7.55 milliseconds, or 34 percent, compared to
placebo. The effect continued to eight months with an average
improvement of 9.13 milliseconds or 41 percent over placebo.
addition, the percentage of subjects whose VEP latency in the affected
eye recovered to normal or nearly normal (within 10 percent of the
normal eye) more than doubled, from 26 percent on placebo to 53 percent
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 Cadavid.
A second study of anti-LINGO-1 in people with multiple sclerosis is ongoing.