More than twice as many people with optic neuritis taking the experimental drug saw nearly full recovery of their vision compared to those on a placebo.
A potentially hopeful vision of the future has emerged for people with multiple sclerosis (MS).
An experimental antibody known as anti-LINGO-1 has been successfully used to repair damage to the fatty insulation of nerves, known as myelin, in MS patients, according to a new study.
The research will be presented next week at the American Academy of Neurology’s 67th annual meeting in Washington, D.C.
Supported by pharmaceutical giant Biogen, the study was designed to measure the visual evoked potential (VEP) in people who had their first occurrence of optic neuritis, a classic precursor condition that often leads to MS.
Optic neuritis is characterized by inflammation and damage to the optic nerve, resulting in vision changes. Using VEP in these patients provided an accurate way to measure nerve repair since conduction across damaged nerves is slower than that of healthy nerves. Theoretically, if anti-LINGO-1 promotes myelin repair, scientists would see improvement in the VEP scores.
For this phase 2 study named RENEW, 82 people who had optic neuritis were first given high-dose steroids. Then they were randomly divided into two groups. One group was treated with the experimental anti-LINGO-1 while the other group received a placebo. It was a “double blind” study meaning neither the volunteers nor the doctors knew which group got which treatment.
“In the RENEW study anti-LINGO-1 was delivered via IV infusion every four weeks for 20 weeks (total of 6 doses),” explained lead study author Dr. Diego Cadavid, senior director of clinical development at Biogen, in an interview with Healthline. Cadavid’s team then followed the patients using the VEP test to measure changes in vision.
The most common side effects seen more in those treated with anti-LINGO-1 were fatigue, nausea, and paresthesia (defined most commonly as a “prickly sensation” or “pins and needles”).
The results showed that those in the anti-LINGO-1 group who didn’t miss more than one dose had “significantly improved [nerve] conduction … compared to people who received the placebo,” according to a press release.
At six months the VEP tests showed those on the drug improved by 34 percent compared to the placebo patients. At eight months the repair was still taking place showing a 41 percent improvement over those on the placebo.
Additionally, 53 percent of patients taking anti-LINGO-1 experienced almost full visual recovery, compared to only 26 percent of those in the placebo group.
“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,” Cadavid, who is also a fellow with the American Academy of Neurology, said in the press release.
While further research is needed to determine if anti-LINGO-1 can consistently show similar results in optic neuritis patients as well as those diagnosed with MS, the results are encouraging.
There are currently 12 FDA-approved treatments for relapsing MS. As scientists learn more about the condition as well as the immune system, the focus of research is shifting from disease management to nerve damage repair, giving new hope to those severely affected by MS. Several ongoing studies are looking at the role of antibodies in triggering an immune response to promote myelin repair.
“A second phase 2 study in people with relapsing forms of MS (called SYNERGY) is ongoing,” Cadavid revealed. “It aims to evaluate the clinical benefit of anti-LINGO-1 when used long term in people with different degrees of MS disability. Results from SYNERGY are expected in 2016.”