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Biogen, Eisai to discontinue late-stage trials in early Alzheimer's

Eisai Co. Ltd. and Biogen Inc. said they will discontinue the phase 3 clinical studies of their medicine elenbecestat to treat patients with early Alzheimer's disease due to an unfavorable risk-benefit ratio.

Cambridge, Mass.-based Biogen and Japanese drugmaker Eisai was evaluating the efficacy and safety of elenbecestat — an inhibitor of the beta-amyloid cleaving enzyme, or BACE, that is believed to play a role in Alzheimer's — against placebo in the phase 3 studies, Mission AD1 and Mission AD2. The studies included about 2,100 patients with mild cognitive impairment or mild Alzheimer's disease with confirmed deposits of amyloid protein in the brain.

The patients were treated for two years and the main goal was improving symptoms on the Clinical Dementia Rating Sum of Boxes scale — a method for diagnosing the severity of dementia symptoms.

The companies said in a Sept. 13 press release that the decision was taken after the data safety monitoring board recommended that they discontinue the trials due to unfavorable risk-benefit ratio.

The companies added that study participants will be contacted to discontinue the investigational treatment.

Detailed data from the studies will be presented at future medical meetings.

In addition, the companies noted that a long-term extension of the phase 2 trial, dubbed Study 202, of elenbecestat will also be discontinued. In July 2018, the companies had reported data that showed that elenbecestat slowed the progression of Alzheimer's disease.

Biogen and Eisai noted that the decision to discontinue the studies does not impact the drug BAN2401, and the phase 3 Clarity trial of BAN2401 in Alzheimer's disease will continue. BAN2401 had failed to meet the main goals of a mid-stage study in December 2017.

In March, the two companies said they were discontinuing two late-stage trials of their Alzheimer's disease drug aducanumab after a futility analysis conducted by an independent data monitoring committee showed that the studies were unlikely to meet their main goals.