16th Jul 2025 09:02
(Alliance News) - AstraZeneca PLC on Wednesday announced that its antibody anselamimab did not achieve statistical significance in the overall patient population, thought it noted a "meaningful improvement" in all-cause mortality in a subgroup of patients.
Anselamimab is a light chain depleter antibody which aims to treat light chain amyloidosis, a rare systemic and progressive disorder caused by defective plasma cells in bone marrow. The disease can cause progressive organ damage and dysfunction, which may lead to death, most commonly due to cardiac failure.
AstraZeneca, a Cambridge, England-based pharmaceutical company, said results from the Cardiac Amyloid Reaching for Extended Survival, CARES, phase III clinical programme showed anselamimab did not achieve statistical significance for the primary endpoint compared to placebo in patients with Mayo stages 3a and 3b light chain amyloidosis.
The primary endpoint was a hierarchical combination of time to all-cause mortality and frequency of cardiovascular hospitalisations, with all patients receiving background standard care for plasma cell dyscrasia, a disorder in which normal plasma cells become transformed in the bone marrow and soft tissues.
However, anselamimab did show highly clinically meaningful improvement in time to all-cause mortality and frequency of cardiovascular hospitalisations in a prespecified subgroup of patients, compared to placebo.
"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. The potential to extend survival and reduce cardiovascular hospitalisations would represent a practice-changing advancement for this patient group," said Ashutosh Wechalekar, lead principal investigator of the programme and professor of Medicine & Haematology at University College London.
AstraZeneca said evaluation of full results is ongoing to further characterise the efficacy and safety of the antibody.
Marc Dunoyer, chief executive at Alexion, AstraZeneca Rare Disease, said: "Alexion is pioneering a novel mechanism of action to address organ damage from existing amyloid deposits in patients with AL amyloidosis, a devastating disease often diagnosed in advanced stages with poor prognosis. Anselamimab is the first and only investigational fibril depleter to show clinical benefit in AL amyloidosis, and these results underscore its potential to address a critical treatment gap in a prespecified subgroup of patients."
AstraZeneca shares fell 1.3% to 10,362.00 pence each on Wednesday morning in London.
By Tom Budszus, Alliance News slot editor
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