Opicinumab (also known as Anti-LINGO-1 and BIIB033) is an investigational fully human monoclonal antibody under development as a potential promoter of remyelination of nerve cells in people with remitting-relapsing RRMS.
Researchers are hopeful that opicinumab promotes the development of oligodendrocytes (cells that make myelin and maintain the myelin coating). MS is characterized by demyelination which interrupts and blocks nerve messages. In earlier stages of MS, oligodendrocytes can repair the damaged myelin, but as MS advances oligodendrocytes stop functioning or are killed off.
The central nervous system has a unique protein in it called LINGO-1 that prevents young cells from becoming oligodendrocytes. Researchers found that opicinumab (also known as anti-LINGO-1) can block the action of LINGO-1, allowing the young cells to mature into oligodendrocytes. These oligodendrocytes might restore damaged myelin.
In an ongoing Phase 1 study (NCT02833142), the pharmacokinetics (how drugs act in the body), safety, and tolerability of single doses of BIIB033 (opicinumab) are being assessed in healthy volunteers and participants with RRMS and secondary-progressive multiple sclerosis (SPMS) compared to a placebo. Preliminary finding show no serious side effects and no difference in the frequency of milder side effects between opicinumab and placebo.
A Phase 2 study called RENEW (NCT01721161) that assessed the effectiveness, safety, and tolerability of BIIB033 (opicinumab) in participants with acute optic neuritis showed that the drug did not improve vision compared to a placebo. However, opicinumab slightly improved and statistically changed the amount of time for a signal to travel from the eye’s retina to the brain. The finding may provide evidence that the myelin sheath around the optic nerve had been repaired, although the dose used was very high and could possibly lead to significant side effects of long-term treatment.
Another Phase 2 study, SYNERGY (NCT01864148), that assessed the effectiveness, safety, tolerability, and pharmacokinetics of BIIB033 (opicinumab) in participants with RRMS treated with Avonex (interferon beta-1a), did not lead to improvement in disability or a slowdown in disability progression. However, the data and evidence of clinical effects will be further analyzed to plan for future studies.
No serious effects occurred in any of the studies as a result of opicinumab.
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