Eisai and Biogen have decided to stop the MISSION AD1 and AD2 phase 3 clinical studies on elenbecestat in early Alzheimer’s disease (AD) owing to safety concerns, as per the latest clinical trial news.

The decision has been driven by the findings of a safety review undertaken by the Data Safety Monitoring Board (DSMB), which asked to stop the late-stage clinical trials because of unfavorable risk-benefit ratio. Eisai and Biogen expect to present detailed data of the two Alzheimer’s disease studies at future medical meetings.

Eisai said that investigators are being told of the decision and they will be contacting their study patients to stop the investigational treatment.

Dr. Lynn Kramer – Eisai Chief Clinical Officer of Neurology Business Group said: “We would like to thank the patients and the families, as well as medical professionals, that participated in the MISSION AD studies. Without their contributions we would not be able to advance Alzheimer’s disease research. We are very disappointed with the news, and intend to learn from these data and continue engaging with patients and investigators, to pursue the discovery of new medicines for Alzheimer’s disease.”

Eisai terminates elenbecestat phase 3 studies in early Alzheimer’s disease. Photo courtesy of KW at Japanese Wikipedia.

Elenbecestat is an oral beta amyloid cleaving enzyme inhibitor (BACE inhibitor).

Its phase 3 clinical trial program, comprised the global clinical trials – MISSION AD1 and MISSION AD2 which had identical protocols. The two multicenter, placebo-controlled, double-blind, parallel-group late-stage clinical studies were to evaluate the efficacy and safety of elenbecestat in nearly 2,100 patients having mild cognitive impairment (MCI) or mild AD (together known as early AD) with confirmed amyloid pathology in the brain.

Patients were randomly grouped to be given 50mg of elenbecestat or placebo everyday during the treatment period of 24 months. The primary endpoint of the phase 3 clinical trials was the Clinical Dementia Rating Sum of Boxes (CDR-SB).

Eisai also said that the long-term extension of the phase 2 clinical trial of elenbecestat will also be terminated. The Japanese pharma company said that its decision will not affect the program of the anti-amyloid beta (Aβ) protofibril monoclonal antibody BAN2401, and also the phase 3 Clarity AD trial evaluating BAN2401, which will both continue.

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