Opicinumab (also known as anti-LINGO-1 and BIIB033) is an investigational fully human monoclonal antibody under development as a potential promoter of the remyelination of nerve cells in people with remitting-relapsing multiple sclerosis (RRMS). Remyelination would allow for the formation of new myelin sheaths around nerve cell axons.
Researchers are hopeful that opicinumab promotes the development of oligodendrocytes (cells that make myelin and maintain the myelin coating). MS is characterized by demyelination (loss of the myelin sheath), which interrupts and blocks the passage of nerve messages. In earlier stages of MS, oligodendrocytes can repair the damaged myelin, but as MS progresses, oligodendrocytes either stop functioning or die, so that myelin repair is no longer ongoing.
The central nervous system (the brain and the spinal cord) has a unique protein called LINGO-1 that prevents immature cells from becoming oligodendrocytes. Researchers found that opicinumab can block the action of LINGO-1 (hence the name, anti-LINGO-1) allowing these cells to mature into oligodendrocytes. These “extra” oligodendrocytes may help to restore damaged myelin, preventing further disability in patients.
A Phase 2 study, called RENEW (NCT01721161), assessed the effectiveness, safety, and tolerability of opicinumab in 82 people with acute optic neuritis, a condition highly associated with MS and characterized by inflammation and demyelination of the optic nerve (the bundle of nerves that transmits visual information from the eye to the brain). Although the results showed no improvements in vision in people taking opicinumab compared to a placebo, there was a slight improvement and statistically significant change in the amount of time it took a signal to travel from the eye to the brain. This finding suggested repair to the myelin sheath around the optic nerve.
A follow-up study, called RENEWed (NCT02657915), assessed the long-term effects of a potential remyelinating therapy in RENEW participants, two years and four months after that trial’s conclusion. RENEWed, which ended in January 2017, assessed eye evoked potential latency (or the delay in electric signals in response to a light stimulus), as well as the clinical progression and severity demyelination in these people. Results have not yet been published.
Another Phase 2 study, SYNERGY (NCT01864148), assessed the effectiveness, safety, tolerability, and pharmacokinetics of opicinumab in 418 RRMS patients being treated concurrently with Avonex (interferon beta-1a). Results found that opicinumab treatment did not lead to improvement in disability, physical or cognitive, or a slowdown in disability progression. However, data and evidence of clinical effects is continuing to be analyzed.
No serious adverse effects of the treatment were reported in any of the studies.
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