Hideki Garren, MD, PHD, Chief Medical Officer at Prothena discusses the clinical data supporting the use of birtamimab to treat AL amyloidosis.
AL amyloidosis is a rare blood disorder associated with the overproduction of amyloid. This leads to the deterioration of vital organs, most notably the heart, kidneys, and liver.
Birtamimab is a monoclonal antibody designed to target and clear the amyloid that accumulates in patients with AL amyloidosis. The orphan drug specifically binds to a defined epitope on kappa and lambda AL protein involved in the disease process.
Recently, findings from the Phase 3 VITAL study were published in Blood and showed that in patients with Mayo Stage IV AL amyloidosis, a post hoc analysis identified a statistically significant survival benefit was observed in patients taking birtamimab. More specifically, a survival benefit of 74% was observed for those treated with birtamimab plus standard of care at 9 months, versus 49% in patients given placebo plus standard of care.
Another Phase 3 trial, the AFFIRM-AL trial, is in development that will evaluate birtamimab in patients with Mayo Stage IV AL amyloidosis based on the post-hoc analysis from the VITAL study. For more information about that study, visit clinicaltrials.gov/NCT04973137.
To learn more about AL amyloidosis and other hematologic disorders, visit checkrare.com/diseases/hematologic-disorders/
