Approval Probability
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Also known as BIIB037, fully human IgG1 anti-Aβ mAb
Aducanumab · 3 trials · 1 indication
Incidence and nature of adverse events (AEs) and serious adverse events (SAEs). Significant assessments reported as AEs or SAEs include clinical laboratory assessments and vital signs, physical and neurological examination, 12-lead electrocardiogram (ECG), and brain MRI findings (including the occurrence of vasogenic edema and incident hemorrhage).
| Arm | Type | Description |
|---|---|---|
| aducanumab IV | EXPERIMENTAL | Infusion of aducanumab over approximately 1 hour |
| aducanumab SC | EXPERIMENTAL | Subcutaneously via injection |
| Cohort 1 | EXPERIMENTAL | IV infusion in cohorts assigned to low dose 1; 1 participant per cohort will receive placebo |
| Cohort 2 | EXPERIMENTAL | IV infusion in cohorts assigned to low dose 2; 1 participant per cohort will receive placebo |
| Cohort 3 | EXPERIMENTAL | IV infusion in cohorts assigned to high dose; 1 participant per cohort will receive placebo |
| Cohort 4 | EXPERIMENTAL | IV infusion in cohorts assigned to mid dose; 1 participant per cohort will receive placebo |
| BIIB037 | EXPERIMENTAL | A single dose of BIIB037 by intravenous infusion. |
| Placebo | PLACEBO_COMPARATOR | A single dose of placebo matching BIIB037 by intravenous infusion. |
| Name | Type | Description |
|---|---|---|
| aducanumab | DRUG | - |
| Placebo | DRUG | IV administration of 0.9% sodium chloride |
| BIIB037 | DRUG | Participants receive a single dose of BIIB037 by intravenous (IV) infusion in cohorts assigned to the following ascending doses: .03 mg/kg, 1 mg/kg, 3 mg/kg, 10 mg/kg, 20 mg/kg, 30 mg/kg, and 60 mg/kg. |
Key Inclusion Criteria: * A minimum weight of 45 kg, inclusive, at Day -1. * All women of childbearing potential and all men must practice highly effective contraception during the study and be willing and able to continue contraception for 24 weeks after study treatment dosing (Day 1). * Must be i...
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Aducanumab is being studied for the treatment of Alzheimer's disease. It is an investigational monoclonal antibody developed by Biogen. The clinical program includes Phase 1 trials in healthy participants and in people with Alzheimer's disease, evaluating its bioavailability and safety.
Aducanumab targets amyloid precursor protein (APP). It is a monoclonal antibody that binds to this target. By binding to APP, it is designed to affect amyloid beta, which is a component of amyloid plaques found in the brains of people with Alzheimer's disease.
Aducanumab is developed by Biogen Inc., which trades on the Nasdaq under the ticker symbol BIIB. Biogen is the sponsor of the clinical trials evaluating the drug in Alzheimer's disease.
Aducanumab is in Phase 1 clinical development. Two Phase 1 trials have been completed: one evaluating absolute bioavailability of a subcutaneous dose in healthy participants, and one assessing single and multiple ascending doses in Japanese participants with Alzheimer's disease.
Aducanumab has been studied in two completed Phase 1 trials. NCT02782975 evaluated the absolute bioavailability of a single fixed subcutaneous dose in healthy participants. NCT02434718 was a single and multiple ascending dose study in Japanese participants with Alzheimer's disease.
Aducanumab is an investigational drug and has not been approved by the FDA. It has received an Accelerated Approval designation, which is a regulatory status that supports expedited development. The drug remains in clinical development for Alzheimer's disease.