What's Happening?
Genentech, a member of the Roche Group, and Alnylam have 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 the comprehensive KARDIA Phase II program, which demonstrated zilebesiran's potential in lowering systolic blood pressure when combined with standard antihypertensives. The trial, named ZENITH, will enroll approximately 11,000 patients globally and is expected to start by the end of 2025.
Why It's Important?
The development of zilebesiran is significant as it addresses the unmet need for effective long-term hypertension management. Despite the availability of antihypertensives, a large percentage of patients fail to achieve adequate blood pressure control, increasing their risk of cardiovascular events. Zilebesiran's twice-yearly dosing could improve adherence and outcomes, potentially reducing healthcare costs and improving patient quality of life. The trial's success could lead to a new standard in hypertension treatment, benefiting millions globally.
What's Next?
The ZENITH trial will focus on evaluating zilebesiran's efficacy in reducing cardiovascular events compared to placebo. If successful, it could lead to regulatory approval and widespread adoption. Stakeholders, including healthcare providers and patients, will be closely monitoring the trial's progress. The trial's outcomes could influence future research and development in RNAi therapeutics for cardiovascular diseases.