BAN2401 is a potential immunotherapy for Alzheimer’s disease that is being jointly developed by U.S.-based biotechnology company Biogen and Japanese healthcare company Eisai. The treatment consists of a monoclonal antibody against a form of beta-amyloid protein that accumulates in the brain of people with Alzheimer’s disease.

How BAN2401 works

Symptoms of Alzheimer’s are caused by brain cell death and a loss of connections between brain cells. It’s not fully understood what causes this cell death, but the disease is characterized by the accumulation of certain proteins in the brain. One of these proteins is beta-amyloid, which can form clumps called plaques that disrupt brain cell communication and may trigger inflammation leading to cell death.

BAN2401 is an antibody designed to bind to one of the versions of beta-amyloid. It is hoped that this binding can neutralize beta-amyloid and help “tag” it so the immune system can clear it from the brain.

BAN2401 in clinical trials

BAN2401 has been tested in two Phase 1 clinical trials (NCT01230853 and NCT02094729) to assess its safety, tolerability, and pharmacokinetics (how the body absorbs, circulates, and processes a medication). Results published for one of these trials (NCT01230853) show that BAN2401 was reasonably safe and well-tolerated at various doses.

There is a large, ongoing Phase 2 clinical trial (NCT01767311) examining the efficacy of various doses of BAN2401 as well as their safety and tolerability. Early analysis of results at 12 months of treatment did not show that BAN2401 is effective in reducing the rate of cognitive decline in Alzheimer’s patients. Cognitive decline was measured by an assessment tool called ADCOMS, and this timeframe for analysis was the trial’s primary endpoint, or goal.

Biogen and Eisai plan to continue the trial until its scheduled conclusion at 18 months, at which point they will assess participants’ cognitive function using the clinical dementia rating sum of boxes (CDR-SOB) as well as ADCOMS. The trial is expected to end in November 2018.

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