Drugs / opicinumab
Trials 8
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 14 trials | ||||||
| Phase 1 | NCT02833142 | Jul → Nov 2016 | multiple sclerosis, optic neuritis | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT02641041 | Feb → Sep 2016 | multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT01244139 | Oct 2010 → Apr 2012 | relapsing-remitting multiple sclerosis | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT01052506 | Jan 2010 → Oct 2011 | — | Biogen | Completed | No outcome recorded |
| Phase 24 trials · 3 missed | ||||||
| Phase 2 | NCT03222973 | Nov 2017 → Feb 2021 | multiple sclerosis | Biogen | Terminated | Missed primary |
| Phase 2 | NCT02657915 | Mar 2016 → Jan 2017 | optic neuritis | Biogen | Completed | Missed primary |
| Phase 2 | NCT01864148 | Aug 2013 → Dec 2015 | multiple sclerosis | Biogen | Completed | Missed primary |
| Phase 2 | NCT01721161 | Dec 2012 → Oct 2014 | optic neuritis | Biogen | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2016-06-07 | Biogen | Results Biogen Reports Top-Line Results from Phase 2 Study of Opicinumab (Anti-LINGO-1) in Multiple Sclerosis biogen.com ↗
Today Biogen (NASDAQ: BIIB) reported top-line results from the Phase 2 SYNERGY study evaluating opicinumab (anti-LINGO-1), an investigational, fully human monoclonal antibody being developed as a potential neuroreparative therapy in people with relapsing forms of multiple sclerosis (RMS). |
| 2016-04-12 | Biogen | Results Biogen Data at 2016 AAN Annual Meeting Highlight Its Expansive Portfolio of MS Therapies That Meets Diverse Needs of Patients biogen.com ↗
Evidence that the Anti-LINGO-1 Monoclonal Antibody BIIB033 Protects Against Multifocal Visual Evoked Potential Amplitude Loss in the Fellow Eye of Subjects with Unilateral Acute Optic Neuritis |
| 2015-04-14 | Biogen | Results Biogen Presents New Anti-LINGO-1 Phase 2 Acute Optic Neuritis Data Demonstrating Neurological Repair biogen.com ↗
Today, Biogen (NASDAQ: BIIB) announced detailed results from the Phase 2 RENEW study of anti-LINGO-1 in acute optic neuritis (AON) – the first clinical study to demonstrate remyelination (the formation of new myelin on axons) following an inflammatory injury in humans. |
| 2012-10-10 | Biogen | Results Biogen Idec’s Commitment to MS Demonstrated Through Significant Scientific Data Being Presented at the 28th ECTRIMS biogen.com ↗
BIIB033 Anti-LINGO-1 antibody reduces optic nerve axonal degeneration in MOG- EAE rodent models – Poster 785 |
All press releases naming this drug 5 releases
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 10 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | opicinumab | “BIIB033 (opicinumab)” NCT02833142 ↗ |
| Known as | Anti-LINGO | ChEMBL registry synonym — accepted as the source's own label CHEMBL3544922 ↗ |
| Known as | BIIB033 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02641041 ↗ |
| Known as | Li81 | “The anti-LINGO-1 antibody Li81 (opicinumab), which blocks LINGO-1 function and shows robust remyelinating activity in animal models” PMID 31928294 ↗ Jan 2020 |
| Action | Inhibit | “blocking the function of another protein called LINGO-1” NCT01244139 ↗ |
| Modality | Protein / enzyme biologic | “BIIB033 is a protein” NCT01244139 ↗ |
| Route | Intravenous | “Single, escalating doses of BIIB033 (8 cohorts IV, 1 cohort SC)” NCT01052506 ↗ |
| Route | Subcutaneous | “Single, escalating doses of BIIB033 (8 cohorts IV, 1 cohort SC)” NCT01052506 ↗ |
| Target | LINGO1 | “blocking the function of another protein called LINGO-1” NCT01244139 ↗ |