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Donanemab slowed Alzheimer's disease progression in phase II trial: full data presented at AD/PD™ 2021 and published in NEJM. Eli Lilly.

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Published:14th Mar 2021
Phase II TRAILBLAZER-ALZ results presented by Eli Lilly and Company at the 15th International Conference on Alzheimer's & Parkinson Diseases 2021 (AD/PD™ 2021) held virtually March 9-14, 2021 and published simultaneously in the New England Journal of Medicine (NEJM) expand on previously reported top-line data that found donanemab met its primary endpoint and showed significant slowing of decline on the integrated Alzheimer's Disease Rating Scale (iADRS), a composite measure of cognition and daily function, in patients with early symptomatic Alzheimer's disease compared to placebo. Additionally, data from secondary analyses showed donanemab consistently slowed cognitive and functional decline, with ranges between 20-40 percent in all secondary endpoints [Clinical Dementia Rating Scale Sum of Boxes (CDR-SB), Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog13), Alzheimer's Disease Cooperative Study-instrumental Activities of Daily Living (ADCS-iADL), Mini-Mental State Examination (MMSE)] with nominal statistical significance at multiple times compared to placebo. Further, prespecified exploratory analyses showed donanemab slowed the accumulation of tau across key brain regions in patients affected by Alzheimer's disease. Specifically, at 76 weeks compared to baseline, treatment with donanemab slowed decline by 32 percent compared to placebo as measured by the iADRS, which was statistically significant . As early as nine months (36 weeks) after initiation of treatment, a significant difference in decline by iADRS was observed. In addition, 40 percent of participants treated with donanemab achieved amyloid negativity as early as six months after starting treatment and 68 percent achieved this target by 18 months. Donanemab is a monoclonal antibody that was designed to bind a specific form of post-translationally modified Aß, N-terminal pyroglutamate, and thereby yield rapid and complete clearance of amyloid plaques. The safety profile of donanemab was consistent with observations from Phase 1 data . In the donanemab treatment group, amyloid-related imaging abnormalities – edema (ARIA-E) occurred in 26.7 percent of treated participants, with an overall incidence of 6.1 percent experiencing symptomatic ARIA-E; the majority ARIA-E cases occurred within the first 12 weeks after initiation of treatment. Other common AEs in the donanemab treatment group include ARIA-H related events like microhemorrhages (7.6 percent) and superficial siderosis of central nervous system (13.7 percent), nausea (10.7 percent), and infusion-related reaction (IRR) (7.6 percent). Serious IRR or hypersensitivity occurred in 2.3 percent of participants treated with donanemab. In the donanemab arm, 30.5 percent of patients discontinued treatment due to an adverse event and half of these discontinuations were due to ARIA-related events. Patients with treatment discontinuations were allowed to continue in the trial.. See- "Donanemab in Early Alzheimer’s Disease"- Mark A. Mintun, M.D., Albert C. Lo, M.D., Ph.D., Cynthia Duggan Evans, Ph.D., et al.-March 13, 2021 DOI: 10.1056/NEJMoa2100708.
Condition: Alzheimers
Type: drug

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