Phase 3 Trials of Elenbecestat in Early Alzheimer’s Stopped for Lack of Benefit, Eisai and Biogen Say

Phase 3 Trials of Elenbecestat in Early Alzheimer’s Stopped for Lack of Benefit, Eisai and Biogen Say
Two global Phase 3 clinical trials — MISSION AD1 (NCT02956486) and MISSION AD2 (NCT03036280) — evaluating elenbecestat as a potential therapy for early Alzheimer’s disease are being stopped early, Eisai and Biogen announced. This decision was based on a safety review conducted by an independent data monitoring committee that found an unfavorable risk-to-benefit ratio for patients. Trial investigators have been informed of the decision to discontinue these studies, and will tell participants to stop using elenbecestat. Data from the MISSION studies will be shared at future medical meetings. “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," Lynn Kramer, chief clinical officer, Neurology Business Group at Eisai, said in a press release. "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," Kramer added. Elenbecestat, being jointly developed by Eisai and Biogen, is an oral inhibitor of BACE, a key enzyme in the production of beta amyloid. By reducing beta-amyloid plaque formation, elenbecestat is designed to lessen its aggregation in the brain and potentially delay Alzheimer’s progression. Results from an 18-month Phase 2 trial, called Study 202 (NCT02322021), that evaluated elenbecestat’s safety and efficacy in early Alzheimer’s found that elenbecestat effectively reduced amyloid buildup in the brain while being safe and well-tolerated. Results were announced in 2018. The double-blind and randomized MISSION AD stud
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