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Also known as Aducanumab, fully human IgG1 anti-Aβ mAb, Aduhelm, Aducanumab-avwa
BIIB037 · 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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BIIB037 is being developed for Alzheimer's Disease. It is an investigational therapy that has been studied in a Phase 1 clinical trial in participants with Alzheimer's Disease. Biogen Inc. is the developer. The drug has not been approved for any indication and remains in clinical development.
BIIB037 targets beta-amyloid, a protein that accumulates in the brains of people with Alzheimer's Disease. By binding to beta-amyloid, the drug is designed to interfere with the amyloid pathway. This mechanism is being explored as a potential approach to treating Alzheimer's Disease.
BIIB037 is being developed by Biogen Inc., which trades on the Nasdaq under the ticker BIIB. Biogen is a biotechnology company focused on neurological and neurodegenerative diseases. The company has conducted clinical research on BIIB037 in Alzheimer's Disease.
BIIB037 is in Phase 1 clinical development. It has completed one Phase 1 trial in participants with Alzheimer's Disease. The drug is investigational and has not been approved by the FDA or any other regulatory agency for any indication.
BIIB037 has been studied in a single Phase 1 trial, NCT01397539, titled Single Ascending Dose Study of BIIB037 in Participants With Alzheimer's Disease. The trial was completed, enrolled 53 participants, and was randomized, double-blind, and placebo-controlled. It was conducted in the United States.