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AstraZeneca PLC (NASDAQ:AZN) announced Wednesday that its Phase III CARES clinical program evaluating anselamimab in patients with light chain (AL) amyloidosis did not achieve statistical significance for its primary endpoint in the overall study population. The primary endpoint combined time to all-cause mortality and frequency of cardiovascular hospitalizations in patients with Mayo stages IIIa and IIIb AL amyloidosis.
According to the company, all participants received standard of care for plasma cell dyscrasia in addition to either anselamimab or placebo. While the overall study did not meet its main objective, AstraZeneca reported that a prespecified subgroup of patients experienced improvement in survival and reduction in cardiovascular hospitalizations when treated with anselamimab compared to placebo.
The CARES program enrolled 406 patients across 19 countries, with 281 patients classified as stage IIIa and 125 as stage IIIb according to the European modification of the Mayo 2004 staging system. Most patients in the trial, around 80%, received daratumumab as part of their treatment regimen.
Ashutosh Wechalekar, lead principal investigator of the trial and Professor of Medicine and Haematology at University College London, stated, “While the study did not meet the primary endpoint in the overall patient population, results from a pre-defined subgroup suggest that anselamimab, by targeting and clearing amyloid deposits, may address a leading cause of organ damage and functional impairment in these patients.”
AstraZeneca said that anselamimab was generally well tolerated, with most adverse events balanced between the treatment and placebo groups. The company indicated that a full evaluation of the results is ongoing, and it plans to share data with global health authorities and present findings at an upcoming medical meeting.
Anselamimab is an investigational monoclonal antibody designed to reduce or eliminate amyloid deposits in tissues and organs. It has received Fast Track Designation from the US Food and Drug Administration and Orphan Drug Designation from regulatory agencies in the US, European Union, and Japan for the treatment of AL amyloidosis.
This information is based on a press release statement contained in a recent SEC filing.
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