Samantha Budd Haeberlein, PhD: The TANGO II Trial of BIIB092

“Essentially what we’re aiming to do is see if BIIB092 has an effect on symptoms in Alzheimer disease.”

Samantha Budd Haeberlein, PhD, the vice president and head of Alzheimer’s Disease, Dementia, and Movement Disorders in Late Stage Clinical Development at Biogen spoke with NeurologyLive at the Alzheimer’s Association International Conference held in Chicago, Illinois, about the TANGO II trial in Alzheimer disease.

The phase II trial is set to evaluate the safety and tolerability of BIIB092, an investigational therapy, in a goal of 528 participants with mild cognitive impairment (MCI) due to Alzheimer disease or mild AD. Additionally, the trial will assess the efficacy of a group of 3 doses of BIIB092—high, medium, and low—in slowing cognitive and functional impairment in participants. Patients will be randomized into 1 of the following 4 arms:

• Intravenous low-dose infusion once every 4 weeks, or once every 12 weeks and placebo at the other 4-week dosing visits to maintain the treatment blind.
• Intravenous medium-dose infusion once every 4 weeks.
• Intravenous high-dose infusion once every 4 weeks.
• Intravenous sham infusion once every 4 weeks.

She also noted that the dive into biomarkers to better understand which patients might respond best to BIIB092—an entirely new area of interest for Biogen. Haeberlein also discussed how in phase I, the therapy bound itself to tau proteins, reducing the tau levels by a significant amount in the cerebral spinal fluid, a promising sign as it moves into larger and later phase testing.