Roche and Alnylam report 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

• KARDIA-2 study met its primary endpoint, demonstrating clinically significant systolic blood pressure reductions in each treatment arm at month three
• Zilebesiran added to a standard of care hypertension medication demonstrated an encouraging safety and tolerability profile in adults with mild to moderate uncontrolled hypertension, and results support the potential for twice-yearly dosing
• Roche and Alnylam have initiated the Phase II KARDIA-3 study in adults with uncontrolled hypertension at high cardiovascular risk
• KARDIA-2 study results will be presented as a late-breaking abstract in April at the 2024 American College of Cardiology Annual Scientific Session

Basel, 05 March 2024 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and Alnylam announced today 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 worldwide¹ - 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.¹ It is a growing global health crisis, responsible for around 10 million deaths worldwide each year.² 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.³ 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.^4-8