Roche, Alnylam’s Zilebesiran meets primary endpoint in KARDIA-1 trial

Breaking news in the world of hypertension treatment, Roche and Alnylam Pharmaceuticals have announced the success of their Phase 2 study KARDIA-1. The investigational RNAi therapeutic Zilebesiran met its primary and secondary endpoints in treating adult patients with hypertension.

Primary and Secondary Endpoints Achieved

Zilebesiran succeeded in significantly reducing systolic blood pressure (SBP) by over 15 mmHg after three months of treatment compared to the placebo. The study also found that these reductions in SBP were consistent and sustained at six months, hinting at the feasibility of quarterly or biannual dosing.

Zilebesiran’s Safety Profile

The Phase 2 study also reported an encouraging safety and tolerability profile in patients with mild-to-moderate hypertension. Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development said, “These early results indicate the potential for zilebesiran to achieve sustained blood pressure reduction with quarterly or biannual dosing.”

Details of the KARDIA-1 Study

The KARDIA-1 study is a multi-center, randomized, double-blind, placebo-controlled study involving 394 adults. Participants either had untreated hypertension or were on stable anti-hypertensive medication therapy.

The Growing Crisis of Hypertension

Hypertension remains a leading cause of mortality, responsible for nearly 10 million deaths globally each year. Despite the availability of multiple treatment options, up to 80% of individuals remain with uncontrolled hypertension, increasing their risk of various diseases.

Roche and Alnylam Partnership

Earlier this year, Roche entered into a partnership with Alnylam to co-develop and co-commercialize Zilebesiran. The KARDIA study program also includes a second Phase 2 study, KARDIA-2, which completed enrollment in June 2023 and expects to publish topline results in early 2024.

The Mechanism of Zilebesiran

Zilebesiran targets angiotensinogen (AGT), a precursor in the Renin-Angiotensin-Aldosterone System (RAAS). By inhibiting AGT synthesis in the liver, Zilebesiran aims to achieve consistent and durable blood pressure reduction over a long period.

This groundbreaking study holds great promise for the future of hypertension treatment and could signify a monumental shift in how the condition is managed.