The study showed significant reductions in blood pressure across three independent cohorts, with encouraging safety profiles. Zilebesiran aims to address treatment gaps in hypertension management and offers the potential for biannual dosing.
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Alnylam Pharmaceuticals, Inc., has announced positive results from the KARDIA-2 Phase 2 study which evaluated the efficacy and safety of Zilebesiran in patients with inadequately controlled hypertension. The study found that a single subcutaneous dose of Zilebesiran, when added to standard antihypertensive medications, resulted in clinically significant reductions in blood pressure.
The primary endpoint of the study was achieved, demonstrating placebo-adjusted reductions in ambulatory systolic blood pressure (SBP) of up to 12.1 mmHg across three independent study cohorts at month 3. Zilebesiran also demonstrated clinically significant reductions in office SBP at month 6.
The study showed an encouraging safety profile for Zilebesiran when added to standard antihypertensive medications. The drug resulted in a higher percentage of patients meeting the blood pressure response criteria compared to placebo. Adverse events were generally mild and resolved without intervention.
These positive results indicate that Zilebesiran, an investigational RNAi therapeutic targeting angiotensinogen, could be a promising treatment option for patients with inadequately controlled hypertension, offering the possibility of consistent blood pressure reduction with just two injections per year. Alnylam has announced a new Phase 2 study, KARDIA-3, to explore its potential as an add-on therapy in high cardiovascular risk patients.
Hypertension, or high blood pressure is a significant health issue worldwide, According to the World Health Organization (WHO), it is estimated that over 1 billion people globally have hypertension. The market for antihypertensive medications is substantial and expected to grow steadily in the coming years.
Dr Manish Saxena, a hypertension specialist at Barts Health NHS Trust and Queen Mary University of London, who led the UK study said: "High blood pressure remains the most important risk for heart attacks and strokes. KARDIA- 2 is a landmark study showing blood pressure lowering benefits and safety of novel therapy Zilebesiran when added to other commonly used medications for blood pressure. It is given every 6 months as an injection that would appeal to millions of blood pressure patients worldwide who have to take blood pressure lowering medication daily. Better blood pressure control with these combinations can significantly reduce risk of heart attacks and strokes in patients."