Press release
Alnylam Presents Detailed Results from the Positive HELIOS-B Phase 3 Study of Vutrisiran▼ in Patients with ATTR Amyloidosis with Cardiomyopathy at the European Society of Cardiology Congress
− In the Overall Population, Achieved 28% Reduction in Primary Composite of All-Cause Mortality and Recurrent Cardiovascular Events, and 31% and 36%
About this update from Alnylam Pharmaceuticals, Inc.
[{"type":"text","content":"\n− In the Overall Population, Achieved 28% Reduction in Primary Composite of All-Cause Mortality and Recurrent Cardiovascular Events, and 31% and 36% Reductions in All-Cause Mortality During the 33-36-Month Double-Blind Period and up to Month 42, Respectively –\n\n\n− In the Monotherapy Population, Reduced Composite Primary Endpoint by 33% and All-Cause Mortality up to Month 42 by 35% –\n\n\n− Strong Trends of Additive Efficacy on Top of Tafamidis Across Primary and Secondary Endpoints –\n\n\n− Demonstrated Statistically Significant Benefits on Multiple Measures of Disease Progression –\n\n\n− Encouraging Safety and Tolerability Profile, Consistent with Established Profile –\n\n\n− Results from HELIOS-B Simultaneously Published in The New England Journal of Medicine –\n\n\n− Alnylam to Host Conference Call Today at 1:00 p.m. BST (8:00 a.m. ET) –\n\n\n−For Investors and Media –\n\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nAlnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced detailed results from the HELIOS-B Phase 3 study of vutrisiran, an investigational RNAi therapeutic in development for the treatment of ATTR amyloidosis with cardiomyopathy (ATTR-CM).\n\n\nThe data were presented today in a Hot Line session at the European Society of Cardiology (ESC) Congress 2024, taking place August 30-September 2 in London, United Kingdom. Results from the HELIOS-B study were also simultaneously published in The New England Journal of Medicine.\n\n\nAs previously reported, the HELIOS-B study met all 10 of its primary and secondary endpoints, across both the overall and monotherapy populations, with statistical significance.\n\n\nEnrolled patients were predominantly New York Heart Association (NYHA) Class I or II with wild-type disease and had been diagnosed by non-invasive methods, with substantial concurrent treatment with available standard of care treatments such as tafamidis and SGLT2 inhibitors – reflecting the contemporary ATTR-CM patient population.\n\n\nIn the study, treatment with vutrisiran substantially reduced the risk of death and cardiovascular events relative to placebo (see table below for further details). In the overall population, vutrisiran reduced the risk of all-cause mortality and recurrent cardiovascular events by 28%, with similar reductions in both the mortality and ca...