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– Study Met Primary Endpoint Demonstrating Clinically Significant Additive Reductions in Ambulatory Systolic Blood Pressure of Up to 12.1 mmHg Across Three Independent Study Cohorts at Month 3 –
– A Single Dose of Zilebesiran Resulted in Clinically Significant Additive Reductions in Office Systolic Blood Pressure at Month 3 and in Time-Adjusted Office Systolic Blood Pressure at Month 6 Across Three Independent Study Cohorts –
– Zilebesiran Demonstrated an Encouraging Safety and Tolerability Profile When Added to Standard of Care Antihypertensives –
– Alnylam to Host Webcast Investor Event Today at 7:00 p.m. ET –
CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced positive results from the KARDIA-2 Phase 2 study evaluating the efficacy and safety of a single subcutaneous dose of zilebesiran when added to one of three standard of care antihypertensives including a thiazide-like diuretic (indapamide), calcium channel blocker (amlodipine) or angiotensin receptor blocker (olmesartan). Zilebesiran is an investigational RNAi therapeutic targeting liver-expressed angiotensinogen (AGT) in development for the treatment of hypertension with the potential for biannual dosing. The results were presented today as a late-breaking clinical trial at the 2024 American College of Cardiology (ACC) Annual Scientific Session. The Company previously announced positive topline results from the KARDIA-2 study in March 2024.
The KARDIA-2 study achieved its primary endpoint demonstrating clinically and statistically significant additive, placebo-adjusted reductions of up to 12.1 mmHg in 24-hour mean systolic blood pressure (SBP) measured by ambulatory blood pressure monitoring (ABPM) when zilebesiran was added to a thiazide-like diuretic, calcium channel blocker or angiotensin receptor blocker, measured independently at Month 3. The study achieved the key secondary endpoint evaluated at Month 3, demonstrating clinically significant additive reductions in office SBP across all three independent cohorts. At Month 6, zilebesiran demonstrated clinically significant and 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. In addition, 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.
“Although many effective oral treatments are available, a large proportion of patients with hypertension are not managed to guideline-recommended targets. Inconsistent adherence to complex, daily, oral medication regimens as well as therapeutic inertia on the part of clinicians may be important contributors to this treatment gap,” said Akshay Desai, M.D., Director of the Cardiomyopathy and Heart Failure Program, Brigham and Women’s Hospital. “Even in those who are treated, residual blood pressure variability may ultimately enhance risk for cardiovascular events. Zilebesiran may help to address many of these limitations of current treatment options. Although further evidence is needed to ensure long term efficacy and safety in a broader population, these data are encouraging and the potential to reduce blood pressure consistently with two injections a year might be transformative for clinical practice.”
KARDIA-2 Study Results
The KARDIA-2 study results are as follows:
Key Endpoint | Indapamide (2.5 mg) | Amlodipine (5 mg) | Olmesartan (40 mg) |
Primary Endpoint: | |||
Change from Baseline to Month 3 in 24-Hour Mean SBP, Assessed by ABPM | - 12.1 mmHg (p | ||
