Roche and Alnylam Report Positive Topline Results from Phase II KARDIA-2 Study

Roche and Alnylam recently announced that the Phase II KARDIA-2 study 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.

“With twice-yearly dosing in combination with standard of care medication, zilebesiran has strong potential to sustain lower blood pressure and reduce the risk of stroke, heart attack and death that can result from inadequate treatment,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “We look forward to continuing the zilebesiran Phase II study programme with Alnylam as we seek to provide transformative impact for millions of people living with uncontrolled hypertension.’’

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 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 designed to evaluate the efficacy of zilebesiran when added to two or more hypertension medications in people with uncontrolled hypertension at high cardiovascular risk.