Positive topline results from the phase II KARDIA-2 study in people with hypertension, demonstrating clinically significant blood pressure reductions with zilebesiran when added to standard of care.- Alnylam + Roche.
Roche and Alnylam announced that the Phase II KARDIA-2 study [NCT05103332] of zilebesiran, an investigational RNAi therapeutic in development for the treatment of hypertension (high blood pressure) - the leading cause of cardiovascular disease worldwide - met its primary endpoint.
People with mild to moderate hypertension treated with zilebesiran added to a standard of care hypertension medication experienced a clinically and statistically significant reduction in systolic blood pressure at month three. Zilebesiran added to a standard of care demonstrated an encouraging safety and tolerability profile.
Hypertension, or high blood pressure, is the leading cause of cardiovascular disease worldwide and a major risk for premature mortality. It is a growing global health crisis, responsible for around 10 million deaths worldwide each year. Approximately one in three adults are living with hypertension globally, and there remains a significant unmet medical need given the poor rates of adherence to existing treatments. Currently, up to 80% of people with hypertension have blood pressure that remains uncontrolled despite the availability of several classes of oral hypertension treatments, leaving them at an increased risk of cardiovascular, cerebrovascular, and renal disease.
The Phase II KARDIA-2 trial results will be presented as a late-breaking abstract at the 2024 American College of Cardiology Annual Scientific Session (6-8 April 2024, Atlanta, Georgia, USA). The KARDIA-2 results build on the positive Phase II KARDIA-1 [NCT04936035] data, presented at the congress of the American Heart Association Scientific Sessions in November 2023, and published in JAMA in February 2024.
Roche and Alnylam have now initiated the global Phase II KARDIA-3 study [NCT06272487] designed to evaluate the efficacy of zilebesiran when added to two or more hypertension medications in people with uncontrolled hypertension at high cardiovascular risk.
About the KARDIA-2 study: The Phase II KARDIA-2 trial is a randomised, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of zilebesiran, when added to a standard of care, in adults with mild-to-moderate hypertension. This global, multicentre trial enrolled 672 adults with hypertension. Patients who met all inclusion/exclusion criteria during a screening period were randomised into three different cohorts to receive open-label therapy with olmesartan, amlodipine or indapamide as their protocol-specified background hypertension medication during a run-in period of at least four weeks. Following the run-in period, eligible patients were randomised 1:1 to receive zilebesiran 600 mg or placebo in addition to their protocol-specified background hypertension medication for six months.
The primary endpoint is the change from baseline mean systolic blood pressure (SBP) at month three, assessed by 24-hour ambulatory blood pressure monitoring (ABPM). Additional endpoints include the change in 24-hour mean SBP after six months of treatment assessed by ABPM, change in office SBP at months three and six, and change in diastolic blood pressure measured by ABPM and office blood pressure at months three and six. Safety will be assessed throughout the study.
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