Opicinumab
monoclonal antibody
Opicinumab (BIIB033) is a fully human monoclonal antibody designed for the treatment of multiple sclerosis, acute optic neuritis (AON), and other associated demyelinating diseases. A biologic drug, it is designed to function as a LINGO-1 protein antagonist, known as "Anti-Lingo-1".
Some Phase II clinical trials have been carried out, but preliminary results indicate that primary study endpoints were not met and that opicinumab exhibits unexpected dose-response relationships. Further studies were planned by the company, as opicinumab still was deemed to show potential for clinical efficacy in the treatment of MS.
Mechanism of action
Opicinumab is designed to prevent the advancement of demyelination associated with neurodegenerative disorders, specifically MS. It is believed to function by allowing young cells, which would normally be prevented from maturing by the LINGO-1 protein, to mature into functional oligodendrocytes. Oligodendrocytes support nerve axons and serve to maintain the myelin sheath that allows for the effective conduction of axon potentials. LINGO-1 is only found in the Central Nervous System (CNS) and is thought to be at least a partial causative agent of MS, an autoimmune disorder. It is thought that by allowing oligodendrocytes to mature, further disability advancement caused by MS can be prevented, with reversal of demyelination associated with MS potentially achievable.
Clinical trials
Phase I and Phase II clinical trials are currently ongoing for opicinumab. Completed Phase I trials assessed safety and efficacy in healthy people and in MS patients, as well as investigated pharmacokinetic parameters of the drug.
Biogen has an ongoing Phase 1 trial that is investigating the safety of ocipinumab produced via two different manufacturing processes in healthy individuals.
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