- Also known as: BIIB033
- Route of Administration: Intravenous Infusion
- Type: Humanized monoclonal antibody
- Reparative therapy
- Emerging treatment for: RRMS
- Status: In Phase II of clinical trials
Anti-LINGO-1 inhibits LINGO-1, to promote neuroprotection and remyelination.
How it Works
LINGO-1 is a protein exclusive to the CNS and expressed by neurons and oligodendrocytes. LINGO-1 can inhibit important processes including myelination, neuronal survival, axonal regeneration, and oligodendrocyte differentiation. Anti-LINGO-1 inhibits LINGO-1 in an effort to promote neuroprotection and remyelination in MS patients.
Research and Results
Phase I studies ( NCT01052506, NCT01244139) examined the effect of ascending doses of BIIB033 or placebo in healthy and MS participants. Results revealed BIIB033 was well tolerated. No serious adverse effects were reported (headache was the most common reported side effect). Results from these phase I studies encouraged further investigation.
A phase II study (SYNERGY) examined the effect of BIIB003 treatment (at various doses) in combination with Avonex (an approved interferon beta-1a treatment) in RRMS participants. Results from this study did not meet the primary endpoints (improvement of neuro-physical and/or cognitive function and/or disability) or secondary endpoints.
A second phase II study (RENEW) investigated the safety and efficacy of BIIB003 treatment in participants affected by acute optic neuritis. Results of the trial were recently announced by Biogen Idec and demonstrated significant improvements in optic nerve performance after 32-week follow-up compared to placebo. The study showed no effect on secondary endpoints, including changes in optic nerve thickness and improvement in visual function.
Adverse Effects Reported
Anti-LINGO-1 appears to be well tolerated. Future studies will provide further insights into possible adverse effects.
Tran, J et al. Safety, tolerability and pharmacokinetics of the anti-LINGO-1 monoclonal antibody BIIB033 in healthy volunteers and subjects with multiple sclerosis. Presented at: 64th American Academy of Neurology Annual Meeting. New Orleans, LA, USA 21-28 April 2012 (P02.021).