Press release
Alnylam Reports Positive Topline Results from KARDIA-1 Phase 2 Dose-Ranging Study of Zilebesiran, an Investigational RNAi Therapeutic in Development to Treat Hypertension in Patients at High Cardiovascular Risk
- Zilebesiran Met Primary Endpoint Demonstrating Greater than 15 mmHg Reduction of Systolic Blood Pressure at Three Months of Treatment Compared to Placebo
About this update from Alnylam Pharmaceuticals, Inc.
[{"type":"text","content":"\n- Zilebesiran Met Primary Endpoint Demonstrating Greater than 15 mmHg Reduction of Systolic Blood Pressure at Three Months of Treatment Compared to Placebo at Two Highest Single Doses Evaluated -\n\n\n- Study Met Key Secondary Endpoints Showing Consistent and Sustained Reductions of Systolic Blood Pressure at Six Months, Supporting Quarterly or Biannual Dosing -\n\n\n- Zilebesiran Demonstrated an Encouraging Safety and Tolerability Profile in Adult Patients with Mild-to-Moderate Hypertension -\n\n\n- Full Study Results to be Presented at an Upcoming Scientific Conference -\n\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nAlnylam Pharmaceuticals, Inc. Nasdaq: ALNY), the leading RNAi therapeutics company, today announced that the KARDIA-1 Phase 2 study of zilebesiran, an investigational RNAi therapeutic targeting liver-expressed angiotensinogen (AGT) in development for the treatment of hypertension, met the primary endpoint demonstrating a dose-dependent, clinically significant reduction in 24-hour mean systolic blood pressure (SBP) measured by ambulatory blood pressure monitoring (ABPM) at Month 3, achieving a placebo-subtracted reduction greater than 15 mmHg (p less than 0.0001) with both 300 mg and 600 mg doses. The study also met key secondary endpoints including significant change in 24-hour mean SBP as measured by ABPM at Month 6, as well as significant change in office SBP at Month 3 and Month 6, for all zilebesiran arms, compared to placebo. The study results indicate zilebesiran was associated with dose-dependent, potent and durable knockdown of serum AGT levels through Month 6. Zilebesiran also demonstrated an encouraging safety and tolerability profile that the company believes supports continued development. These findings of robust and tonic blood pressure control will help determine the optimal dose and regimen of zilebesiran for future studies.\n\n\n“Hypertension is a growing global health crisis responsible for around 10 million deaths worldwide each year. Despite the availability of several classes of oral anti-hypertensive treatments, up to 80% of individuals globally remain uncontrolled, leaving them at an increased risk of cardiovascular, cerebrovascular and renal disease, which is further exacerbated by blood pressure variability, lack of nighttime blood pressure control and poor adherence,” said Professor George ...