Biogen and Eisai discontinue Phase 3 Alzheimer’s trial
pharmafile | March 21, 2019 | News story | Research and Development | Alzheimer's, Biogen, CNS, Eisai, mental health
Biogen and Eisai have announced their decision to discontinue a Phase 3 trial looking into the efficacy and safety of aducanumab in patients with mild cognitive impairment due to Alzheimer’s disease.
The decision came after analysis found the trials were unlikely to meet their primary endpoint upin completion. The recommendation to end the trials was not based on safety concerns.
“This disappointing news confirms the complexity of treating Alzheimer’s disease and the need to further advance knowledge in neuroscience. We are incredibly grateful to all the Alzheimer’s disease patients, their families and the investigators who participated in the trials and contributed greatly to this research,” said Michel Vounatsos, Chief Executive Officer at Biogen.
“Biogen’s history has been based on pioneering innovation, learning from successes and setbacks. Driven by our steadfast commitment to patients and our strong business foundation, we will continue advancing our pipeline of potential therapies in Alzheimer’s disease and innovative medicines for patients suffering from diseases of high unmet need.”
The primary objective of the ENGAGE and EMERGE trials was to evaluate the efficacy of monthly doses of aducanumab as compared with placebo in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score. Secondary objectives were to assess the effect of monthly doses of aducanumab as compared to placebo on clinical progression as measured by Mini-Mental State Examination (MMSE), AD Assessment Scale-Cognitive Subscale (ADAS-Cog 13), and AD Cooperative Study-Activities of Daily Living Inventory (ADCS-ADL-MCI).
The decision comes after US multinational Pfizer chose to pull out of Alzheimer’s research in 2018. Research into Alzheimer’s has brought about a series of disapointments for major pharmaceutical companies including Merck, biogen and Eli Lily in recent years.
Louis Goss
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