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Alnylam Reports Positive Topline Results from HELIOS-B Phase 3 Study of Vutrisiran, Achieving Statistical Significance on Primary and All Secondary Endpoints in Both Overall and Monotherapy Populations

Published: 2024-06-24 11:00:00 ET

− Achieved 28% and 33% Reduction in Composite of All-Cause Mortality and Recurrent Cardiovascular Events in the Overall and Monotherapy Populations, Respectively –

− Reduced All-Cause Mortality by 36% and 35% in the Overall and Monotherapy Populations, Respectively, in a Pre-Specified Secondary Endpoint –

− Demonstrated Clinically Significant Benefits on 6-Minute Walk Test, Kansas City Cardiomyopathy Questionnaire and NYHA Class – Key Measures of Disease Progression –

− Observed Consistent Effects in All Key Subgroups, Including Baseline Tafamidis –

− Demonstrated Encouraging Safety, Consistent with Established Profile –

− Alnylam to File a U.S. Supplemental New Drug Application Using a Priority Review Voucher –

− Alnylam to Host Conference Call Today at 8:00 am ET –

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced positive topline results from its HELIOS-B Phase 3 study of vutrisiran, an investigational RNAi therapeutic in development for the treatment of ATTR amyloidosis with cardiomyopathy (ATTR-CM).

The study met the primary endpoint, demonstrating a statistically significant reduction in the composite of all-cause mortality and recurrent cardiovascular (CV) events during the double-blind period in both the overall population (HR 0.718, p-value 0.0118; n=654) and in the monotherapy population (patients not receiving tafamidis at baseline; HR 0.672, p-value 0.0162; n=395).

The study also demonstrated statistically significant improvements across all secondary endpoints in both the overall and monotherapy populations. This includes key measures of disease progression: 6-minute walk test (6-MWT), Kansas City Cardiomyopathy Questionnaire (KCCQ) and New York Heart Association (NYHA) Class at Month 30 (p

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All statements made via social media sites sponsored or maintained by Enhanced Investments and its affiliates are for informational purposes only and do not constitute a comprehensive description of Enhanced Investments' investment advisory services.
Certain investments are not suitable for all investors. Before investing, consider your investment objectives and applicable fees. The rate of return on investments can vary widely over time, especially for long term investments. Investment losses are possible, including the potential loss of all amounts invested. Information provided by Enhanced Investments is for informational and general educational purposes only and is not investment or financial advice.