Zilebesiran to Be Tested in High-Risk Hypertension Trial

In order to determine whether zilebesiran, an RNAi therapy, might lower the risk of serious adverse cardiovascular events in patients with uncontrolled hypertension, Roche and Alnylam announced their intention to start a Phase III cardiovascular outcomes study (CVOT).

This decision was based on the larger KARDIA Phase II program comprised of KARDIA 1, KARDIA 2 and more recently KARDIA-3 assessing the safety and efficacy of zilebesiran in patients with uncontrolled hypertension, at high cardiovascular (CV) risk on two to four standards of care antihypertensives.

More specifically, KARDIA-3 aimed to define the patient population that would be studied in the Phase III CV outcomes trial.

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“Zilebesiran has the potential to become a best-in-disease treatment for many patients with uncontrolled hypertension. Its blood pressure-lowering effects and twice-yearly dosing could reduce the risk of serious health complications and death,” said Levi Garraway, MD, PhD, Roche’s chief medical officer and head of Global Product Development.

“Detailed analysis of our comprehensive Phase II clinical trials has informed our decision to move zilbesiran into Phase III. Despite current treatment options, up to 80% of people with hypertension do not achieve adequate blood pressure control putting them at higher risk of cardiovascular events. Therefore, additional treatment options are needed."