Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as BIIB033 (opicinumab), BIIB033 (anti-LINGO-1 mAb), anti-LINGO-1 mAb
BIIB033 · 6 trials · 4 indications
A full field visual evoked potential (FF-VEP) is an evoked potential caused by a visual stimulus, such as an alternating checkerboard pattern on a computer screen. Responses are recorded from electrodes that are placed on the back of the head and are observed as a reading on an electroencephalogram (EEG). These responses usually originate from the occipital cortex, the area of the brain involved in receiving and interpreting visual signals.
Estimated proportion of participants experiencing confirmed improvement in any 1 or more of the following components: a ≥1 point decrease in the Expanded Disability Status Scale (EDSS) score from a baseline score of \<=6.0 (decrease sustained for ≥3 months); a ≥15% improvement from baseline in time to complete 9-Hole Peg Test (9HPT) by either hand (improvement sustained for ≥3 months for the same hand), where the time is the average time of 2 trials per hand at the same visit; a ≥15% improvement from baseline in time to complete Timed 25-Foot Walk (T25FW) test (improvement sustained for ≥3 months), where the time is the average time of 2 trials at the same visit; or a ≥15% improvement from baseline 3-Second Paced Auditory Serial Addition Test (PASAT-3) score (improvement sustained for 3 months or greater). Estimated proportion of responders is based on logistic regression adjusted for multiple sclerosis (MS) type, region and baseline component assessments.
Adjusted mean change in optic nerve conduction velocity (NCV) at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by FF-VEP. Adjusted for the baseline latency of fellow eye.
Adjusted mean change in optic nerve conduction velocity (NCV) at Week 24 for the affected eye from the baseline of unaffected fellow eye as determined by FF-VEP. Adjusted for the baseline latency of fellow eye.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | This was a follow-up study, investigational product was administered in the previous study. Participants in the placebo arm have received at least 1 dose of placebo. |
| BIIB033 100mg/Kg | EXPERIMENTAL | This was a follow-up study, investigational product was administered in the previous study. Participants in the BIIB033 arm have received at least 1 dose of 100 mg/kg BIIB033. |
| BIIB033, 3 mg/kg | EXPERIMENTAL | BIIB033 3 mg/kg once every 4 weeks intravenous (IV) infusion up to Week 72. Avonex once-weekly intramuscular (IM) injection up to Week 84. |
| BIIB033, 10 mg/kg | EXPERIMENTAL | BIIB033 10 mg/kg once every 4 weeks IV infusion up to Week 72. Avonex once-weekly IM injection up to Week 84. |
| BIIB033, 30 mg/kg | EXPERIMENTAL | BIIB033 30 mg/kg once every 4 weeks IV infusion up to Week 72. Avonex once-weekly IM injection up to Week 84. |
| BIIB033, 100 mg/kg | EXPERIMENTAL | BIIB033 100 mg/kg once every 4 weeks IV infusion up to Week 72. Avonex once-weekly IM injection up to Week 84. |
| BIIB033 | EXPERIMENTAL | Participants will receive BIIB033 once every 4 weeks for 20 weeks (a total of 6 doses). |
| BIIB033-A | EXPERIMENTAL | Staggered single dosing schema |
| BIIB033-B | EXPERIMENTAL | Staggered single dosing schema |
| Cohort 1 | EXPERIMENTAL | A single IV dose of 10 mg/kg BIIB033 or placebo given on Day 1 |
| Cohort 2 | EXPERIMENTAL | A single IV dose of 30 mg/kg BIIB033 or placebo given on Day 1 |
| Cohort 3 | EXPERIMENTAL | One IV dose of 100 mg/kg BIIB033 or placebo given on Days 1 and 15 |
| Active study drug | EXPERIMENTAL | Treatment |
| Comparator | EXPERIMENTAL | Dummy drug |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Administered as specified in the treatment arm. |
| BIIB033 100mg/Kg | DRUG | Administered as specified in the treatment arm. |
| BIIB033 | DRUG | - |
| Avonex | DRUG | - |
| BIIB033 (anti-LINGO-1 mAb) | BIOLOGICAL | 100 mg/kg via IV infusion once every 4 weeks for 20 weeks (a total of 6 doses). |
| BIIB033 (opicinumab) | DRUG | - |
Key Inclusion Criteria: * Must have participated in Study NCT01721161 and received at least 1 dose of BIIB033 or placebo, as per protocol, within 2 years (+ 4 months) from Day 1 of this study (2 years from Week 32 or projected Week 32 visit, if the subject did not complete all visits in Study NCT01...
BIIB033 is an investigational monoclonal antibody being studied for neurologic conditions including acute optic neuritis, multiple sclerosis, relapsing-remitting multiple sclerosis, and central nervous system demyelinating disease. It is not approved for any indication and remains in clinical development. Biogen Inc. (ticker BIIB) is the developer.
BIIB033 targets LINGO-1, a protein that regulates neuronal survival and axon regeneration. By binding LINGO-1, the antibody is designed to promote remyelination and repair of damaged nerve fibers in demyelinating conditions such as multiple sclerosis and acute optic neuritis. It is a monoclonal antibody modality.
BIIB033 is developed by Biogen Inc., which trades on Nasdaq under the ticker BIIB. Biogen sponsored the clinical trials evaluating the antibody in multiple sclerosis and acute optic neuritis. The drug is also known as opicinumab.
Yes. BIIB033 is the same drug as opicinumab, an anti-LINGO-1 monoclonal antibody. Other names used in study documentation include BIIB033 (anti-LINGO-1 mAb), BIIB033 100mg/Kg, and BIIB033/Kg. All refer to the same investigational Biogen compound.
BIIB033 is in Phase 2 development. It is investigational and has not been approved by the FDA for any indication. Biogen has completed Phase 1 and Phase 2 trials in multiple sclerosis and acute optic neuritis, and no trials are currently active.
Completed trials include NCT01864148, a Phase 2 study of BIIB033 with Avonex in relapsing multiple sclerosis enrolling 419 participants, and NCT02657915, a Phase 2 long-term remyelinating therapy assessment in acute optic neuritis. Phase 1 studies NCT02833142 and NCT02641041 evaluated pharmacokinetics, safety, and tolerability.