Alnylam Pharmaceuticals reported new data from its HELIOS-B Phase 3 study evaluating vutrisiran in patients with transthyretin-mediated amyloidosis with cardiomyopathy (ATTR-CM). The company said results presented at the European Society of Cardiology (ESC) Congress 2025 demonstrated sustained cardiovascular benefit over a median of 36 months.
According to Alnylam, treatment with vutrisiran resulted in a lower risk of all-cause mortality and recurrent cardiovascular hospitalizations compared to placebo. The company claims the therapy also showed improvements in functional capacity and quality-of-life measures.
The company stated that vutrisiran maintained an acceptable safety profile throughout the study period, with adverse events consistent with prior clinical findings.
Alnylam said that HELIOS-B is the first and largest global Phase 3 study of an RNAi therapeutic in ATTR-CM, involving more than 600 patients across 20 countries.
The company added that it plans to discuss the results with global regulatory authorities and anticipates that the findings will support broader adoption of vutrisiran as a treatment for ATTR-CM.
