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AstraZeneca's AL Amyloidosis Drug Misses Goal in Late-Stage Studies
ZACKSยท 2025-07-17 18:10
Core Insights - AstraZeneca (AZN) reported disappointing results from two late-stage studies evaluating its investigational antibody anselamimab for treating light chain (AL) amyloidosis [1][7] - Both studies aimed to assess the efficacy of anselamimab plus standard care against placebo, focusing on all-cause mortality and cardiovascular hospitalizations [2][3] - The treatment did not achieve statistical significance for the primary endpoint in either study, although a clinically meaningful improvement was noted in a prespecified subgroup [3][7] - AstraZeneca plans to conduct a full analysis of the results and present findings at a future medical meeting [3][7] Disease Context - AL amyloidosis is caused by amyloid protein deposits due to defective plasma cells, leading to organ damage and potential premature death, primarily from cardiac failure [4] - Approximately 74,000 people globally are affected by AL amyloidosis [4] Market Performance - Year to date, AstraZeneca's shares have increased by 7%, contrasting with a 1% decline in the industry [5] Industry Setbacks - AstraZeneca is not alone in facing setbacks in the AL amyloidosis treatment space, as Prothena (PRTA) also reported a failure with its drug birtamimab in a similar study [8][9] - Prothena's AFFIRM-AL study did not meet its primary endpoint, leading to the termination of birtamimab's development and a significant workforce reduction [9]