Roche and Alnylam announced the decision to initiate a Phase III cardiovascular outcomes trial (CVOT) to evaluate the ability of zilebesiran, a RNAi therapeutic, to reduce the risk of major adverse cardiovascular events in patients with uncontrolled hypertension.

This decision was informed by the comprehensive KARDIA Phase II programme, including KARDIA 1, KARDIA 2 and the most recent KARDIA-3 study evaluating the efficacy and safety of zilebesiran in patients with uncontrolled hypertension and high cardiovascular (CV) risk, on two to four standard of care antihypertensives. In particular, KARDIA-3 aimed to define the patient population to be investigated in the Phase III CV outcomes trial.

“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 have 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."