Roche and Alnylam report positive topline results from Phase 2 study KARDIA-1 of zilebesiran, an investigational RNAi therapeutic in development to treat hypertension in patients at high risk of cardiovascular disease

Zilebesiran met primary endpoint demonstrating greater than 15 mmHg reduction of systolic blood pressure at three months of treatment compared to placeboStudy met key secondary endpoints showing consistent and sustained reductions of systolic blood pressure at six monthsZilebesiran demonstrated an encouraging safety and tolerability profile in adult patients with mild-to-moderate hypertensionFull study results to be presented at an upcoming scientific conferenceBasel, 7 September 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) and Alnylam announced today that the Phase 2 study KARDIA-1 of zilebesiran, an investigational RNAi therapeutic targeting liver-expressed angiotensinogen (AGT), met the primary endpoint. Zilebesiran demonstrated a clinically significant reduction in 24-hour mean systolic blood pressure (SBP) at month three, achieving a placebo-subtracted reduction greater than 15 mmHg with both 300 and 600 mg doses (p< 0.0001). 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.“These early results indicate the potential for zilebesiran to achieve sustained blood pressure reduction with quarterly or biannual dosing,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical ...
Source: Roche Media News - Category: Pharmaceuticals Source Type: news