Undeterred by the failure of one of its Alzheimer's pipeline assets, Eisai Co., Ltd ESALY is stepping up efforts to further advance its clinical pipeline.
Apart from aducanumab — for which trials were scrapped — the company has two more assets for Alzheimer's, namely BAN2401 and elenbecestat, both of which target amyloid plaques in the brain.
What Happened
Eisai, which is partnering with Biogen Inc BIIB on Alzheimer's research, announced the initiation of a global Phase 3 clinical study Thursday, dubbed Clarity AD/Study 301, of BAN2401, which is being evaluated in patients with early Alzheimer's disease.
BAN2401 is a monoclonal antibody that acts against beta-amyloid protein that forms clumps called plaques in the brain, impairing connections between brain cells and triggering inflammation, leading to cell death, both of which are responsible for the onset of Alzheimer's.
The proposed global trial is a placebo-controlled, double-blind, parallel-group, randomized study evaluating 1,566 patients with mild cognitive impairment due to Alzheimer's with confirmed amyloid pathology in the brain.
Eisai said the Phase 3 study is intended to support a regulatory filing for the asset following discussion with regulatory agencies based on the results of a Phase 2 study.
The primary endpoint is the change from the baseline in the Clinical Dementia Rating-Sum of Boxes at 18 months of treatment, Eisai said.
What's Next
In a separate release, Eisai said it will make a total of seven presentations on BAN2401 and the oral beta amyloid cleaving enzyme inhibitor elenbecestat at the 14th International Conference on Alzheimer's & Parkinson's Diseases March 26 and March 31 in Lisbon, Portugal.
The decision to scrap aducanumab trials wiped about $18.4 billion from Biogen's market value, as its shares slumped 29.23 percent to $226.88 at Thursday's close. Eisai ended 17.5 percent lower at the Tokyo Exchange Friday.
Biogen shares were down 1.9 percent at $222.58 at the time of publication Friday, while the OTC-listed Eisai shares were advancing 5.99 percent to $55.75.
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