What is the story about?
What's Happening?
Alnylam Pharmaceuticals has announced the initiation of a Phase 3 cardiovascular outcomes trial for zilebesiran, an investigational RNAi therapeutic. The decision follows promising results from the KARDIA Phase 2 program, which demonstrated zilebesiran's ability to reduce blood pressure in patients with uncontrolled hypertension and high cardiovascular risk. The Phase 3 trial, named ZENITH, will evaluate zilebesiran's potential to reduce major adverse cardiovascular events in approximately 11,000 patients globally. The trial is expected to start by the end of 2025, with zilebesiran administered biannually at a 300 mg dose. The KARDIA-3 study showed significant reductions in systolic blood pressure, supporting the design and dosing regimen for the upcoming trial.
Why It's Important?
The initiation of the Phase 3 trial for zilebesiran is significant as it addresses the global health crisis of cardiovascular disease, largely driven by uncontrolled hypertension. Hypertension is a leading modifiable risk factor for cardiovascular disease, affecting millions worldwide. Zilebesiran's ability to provide sustained blood pressure control could lead to improved cardiovascular outcomes, offering a novel approach to managing hypertension. The trial's success could pave the way for a new class of RNAi therapeutics, potentially transforming treatment strategies for patients with high cardiovascular risk.
What's Next?
Alnylam and its partner Roche plan to advance zilebesiran into the global Phase 3 ZENITH trial by the end of 2025. The trial will enroll patients with uncontrolled hypertension and high cardiovascular risk, evaluating the impact of zilebesiran on reducing cardiovascular events. The results could influence future treatment guidelines and expand the use of RNAi therapeutics in cardiovascular medicine. Stakeholders, including healthcare providers and patients, will be closely monitoring the trial's progress and outcomes.
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