A new study suggests
that an investigational drug for multiple sclerosis (MS) may repair myelin
according to a study 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.
The 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.
All 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.
The 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.
In 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.
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