What's Happening?
Genentech, in collaboration with Alnylam, has announced the initiation of a Phase III cardiovascular outcomes trial for zilebesiran, an RNAi therapeutic aimed at reducing major adverse cardiovascular events in patients with uncontrolled hypertension. This decision follows promising results from the KARDIA Phase II program, which demonstrated zilebesiran's ability to lower systolic blood pressure significantly. The trial, named ZENITH, will enroll approximately 11,000 patients globally and evaluate the efficacy of zilebesiran administered biannually. The drug targets angiotensinogen synthesis in the liver, potentially offering a long-term solution for blood pressure management.
Why It's Important?
Hypertension is a leading modifiable risk factor for cardiovascular disease, affecting millions worldwide. Despite existing treatments, a significant portion of patients fail to achieve adequate blood pressure control, increasing their risk of cardiovascular events. Zilebesiran's potential to offer sustained blood pressure reduction with biannual dosing could revolutionize hypertension management, improving patient adherence and outcomes. This development is crucial for healthcare systems, as it may reduce the burden of uncontrolled hypertension and associated complications.
What's Next?
The ZENITH trial is expected to commence by the end of 2025, pending regulatory approval. It will focus on patients with established cardiovascular disease or those at high risk, already on multiple antihypertensives. The trial's results could lead to zilebesiran becoming a standard treatment option, influencing clinical guidelines and patient care strategies. Stakeholders, including healthcare providers and policymakers, will closely monitor the trial's progress and outcomes.
