opicinumab   Click here for help

GtoPdb Ligand ID: 8923

Synonyms: BIIB-033 | BIIB033
Compound class: Antibody
Comment: Opicinumab is a monoclonal antibody which acts as a functional antagonist of the neural protein, LINGO1 [2-3]. Opicinumab was investigated for its clinical utility in diseases with underlying immune-driven demyelination.
Peptide sequence and structural information for this antibody are available from its IMGT/mAb-db record. A BLAST search of patented peptide sequences reveals a 100% match between the variable heavy chain region of opicinumab and SEQ ID NO: 5 from patent US8058406 B2, and another identical match between the variable light chain of the antibody and the patent's SEQ ID NO: 13 [2].
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No information available.
Summary of Clinical Use Click here for help
Opicinumab reached Phase 2 clinical trial as a potential therapy for multiple sclerosis (MS) and for acute demyelinating optic neuritis [6].
Phase 1 results were reported in [7], which indicated good satety, tolerability and pharmacokinetic profiles in healthy subjects and MS patients. In 2020 Biogen terminated this clinical programme in response to results from their phase 2 AFFINITY study in MS which did not meet its primary or secondary endpoints.
Mechanism Of Action and Pharmacodynamic Effects Click here for help
The mechanism of LINGO1 blockade as a CNS repair therapeutic is reveiewd in [4] and [5]. Anti-LINGO1 antibody treatment promotes oligodendrocyte survival, differentiation and myelination in vitro and in vivo [2] in disease models.
Clinical Trials
Clinical Trial ID Title Type Source Comment References
NCT02833142 Pharmacokinetics, Safety and Tolerability of Single Doses of BIIB033 (Opicinumab) Produced by 2 Manufacturing Processes Phase 1 Interventional Biogen 7
NCT03222973 Efficacy and Safety of BIIB033 (Opicinumab) as an Add-on Therapy to Disease-Modifying Therapies (DMTs) in Relapsing Multiple Sclerosis (MS) Phase 2 Interventional Biogen Known as the AFFINITY study: failed to meet primary and secondary endpoints, leading to termination of Biogen's opicinumab programme in October 2020.
NCT01721161 BIIB033 In Acute Optic Neuritis (AON) Phase 2 Interventional Biogen The RENEW study: no significant difference in the remyelination was detected between the opicinumab and placebo groups following 24 weeks in the trial. The treatment group received 6 doses (100 mg/kg i.v.) over the 24 week treatment period. 1