Roche, Alnylam report Phase 2 KARDIA-1 study of zilebesiran met primary endpoint

Roche (RHHBY) and Alnylam (ALNY) announced that the Phase 2 study KARDIA-1 of zilebesiran, an investigational RNAi therapeutic targeting liver-expressed angiotensinogen, met the primary endpoint. Zilebesiran demonstrated a clinically significant reduction in 24-hour mean systolic blood pressure at month three, achieving a placebo-subtracted reduction greater than 15 mmHg with both 300 and 600 mg doses. The study also met key secondary endpoints showing consistent and sustained reductions of SBP at six months supporting quarterly or biannual dosing. In addition, the study showed that zilebesiran was associated with a potent and durable reduction of serum AGT levels through month six while demonstrating an encouraging safety and tolerability profile. The topline results of KARDIA-2 are expected in early 2024, the companies noted. “These early results indicate the potential for zilebesiran to achieve sustained blood pressure reduction with quarterly or biannual dosing. Also, these data underscore the potential of this investigational medicine to provide transformative impact for many people living with uncontrolled hypertension,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. Earlier this year, Roche entered the partnership with Alnylam to co-develop and co-commercialise zilebesiran. The KARDIA study program also includes the Phase 2 study KARDIA-2 of zilebesiran used in combination with one of three standard classes of anti-hypertensive medications which completed enrollment in June 2023.