The KARDIA-2 Phase 2 study evaluated the efficacy and safety of zilebesiran, an RNAi therapeutic targeting hypertension, when added to standard antihypertensive medications.
• Zilebesiran demonstrated clinically significant additive reductions in ambulatory systolic blood pressure (SBP) of up to 12.1 mmHg at Month 3, when added to thiazide-like diuretics, calcium channel blockers, or angiotensin receptor blockers.
• Zilebesiran achieved clinically significant additive reductions in office SBP at Month 3 across all three independent cohorts.
• At Month 6, zilebesiran sustained placebo-adjusted, time-adjusted reductions in office SBP when added to indapamide, amlodipine, and olmesartan, despite the addition of rescue antihypertensives at Month 3.
• Zilebesiran resulted in clinically significant placebo-adjusted, time-adjusted reductions in 24-hour mean SBP, assessed by ABPM, when added to indapamide and amlodipine, sustained to Month 6.
• A non-statistically significant result was observed when zilebesiran was added to the maximum dose of olmesartan when evaluated by time-adjusted change from baseline in 24-hour mean SBP, assessed by ABPM at Month 6.
Zilebesiran exhibited an encouraging safety and tolerability profile when added to standard of care antihypertensives.
These results suggest that zilebesiran, with its potential for biannual dosing, may offer a novel and effective treatment option for patients with inadequately controlled hypertension. By addressing the challenges of adherence and therapeutic inertia, zilebesiran has the potential to improve blood pressure control and reduce cardiovascular risk.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.