(NIH.gov)
15 April 2015. A clinical trial testing a new therapy for multiple sclerosis shows the drug improves the performance of optic nerves in patients with acute optic neuritis, a condition highly associated with multiple sclerosis. Researchers from the biotechnology company Biogen present their findings next week at the annual meeting of American Academy of Neurology in Washington, D.C.
Multiple sclerosis is an autoimmune condition where the immune system attacks the central nervous system and damages myelin, the fatty, protective substance around nerve fibers, as well as nerve cells themselves. Scar tissue from the damaged myelin, known as sclerosis, distorts the nerve signals sent to and from the brain and spinal cord, causing symptoms ranging from mild numbness to loss of vision or paralysis. Optic neuritis is inflammation of the optic nerve that transmits visual information from the eye to the brain, leading to pain and temporary vision loss, and is considered an indicator of multiple sclerosis.
Biogen, in Cambridge, Massachusetts, is developing an antibody treatment for multiple sclerosis and optic neuritis that aims to block a neurologic protein called Lingo-1 that normally supports myelin growth on nerve cells. In people with multiple sclerosis, however, Lingo-1 proteins appear to limit rather than encourage myelin growth when it binds to its receptors. Biogen’s antibody, code-named BIIB033, is designed to block the actions of Lingo-1, allowing for myelin to regrow.
The intermediate-stage clinical trial enrolled 82 adults with acute optic neuritis who were randomly assigned to receive 6 infusions of BIIB033 or a placebo every 4 weeks over a 20-week period. Participants were then assessed every four weeks up to 6 months, with a final evaluation 8 months after the last infusion. The study looked primarily at responsiveness of the optic nerves between participants’ damaged and normal eyes, as indicators of myelin restoration around nerve fibers, measured by ability to conduct electrical signals between the retina and the brain.
Results show participants receiving BIIB033 showed faster average optic nerve response of 7.6 milliseconds or 34 percent after 6 months compared to their counterparts receiving a placebo. After 8 months, average optic nerve response improved to 9.1 milliseconds, or 41 percent, compared to the placebo group. In addition, more than half (53%) of participants receiving BIIB033 showed optic nerve responses in their damaged eyes within 10 percent of their normal eyes, compared to about a quarter (26%) of those receiving the placebo.
The trial also measured changes in thickness of optic nerve cells and fibers using optical coherence tomography, similar to MRI and ultrasound imaging, but found little change in nerve cell or fiber thickness as a result of the treatments. The researchers point to the extensive damage to patients’ optic nerves as a probable cause. The study reported as well that treatments of BIIB033 were well tolerated with comparable rates and severity of adverse effects — generally fatigue, nausea, and sensations of burning or tingling — between patients receiving the test drug or the placebo.
Biogen has another intermediate-stage clinical trial underway testing BIIB033 among people with multiple sclerosis, and expects to report its first results next year.
Read more:
- Lilly Acquiring Treatment for Autoimmune Disorders
- Multiple Sclerosis Patients to Crowdsource Health Data
- Autoimmune Therapy Developer Raises $23M in Early Funds
- Grant Funding Crowdsourced Multiple Sclerosis Drug Trial
- Myelin Foundation to Assess Multiple Sclerosis Treatment
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