Alnylam: KARDIA-1 Phase 2 Dose-Ranging Study Of Zilebesiran Meets Primary Endpoint

(RTTNews) - RNAi therapeutics company Alnylam Pharmaceuticals, Inc. (ALNY) announced Thursday positive topline results from the KARDIA-1 Phase 2 study of zilebesiran.

zilebesiran is an investigational RNAi therapeutic targeting liver-expressed angiotensinogen or AGT in development for the treatment of hypertension in patients at high cardiovascular risk.

The KARDIA-1 Phase 2 trial is a randomized, double-blind, placebo-controlled, multi-center global dose-ranging study designed to evaluate the efficacy and safety of zilebesiran as monotherapy in adults with mild-to-moderate hypertension.

The trial met the primary endpoint demonstrating a dose-dependent, clinically significant reduction in 24-hour mean systolic blood pressure or SBP measured by ambulatory blood pressure monitoring or ABPM at Month 3. It achieved a placebo-subtracted reduction greater than 15 mmHg 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 company said the latest trial findings of robust and tonic blood pressure control will help determine the optimal dose and regimen of zilebesiran for future studies.

Alnylam noted that the KARDIA-2 Phase 2 study of zilebesiran used in combination with one of three standard classes of anti-hypertensive medications completed enrollment in June 2023. Topline results are expected in early 2024.

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