ALNY/RHHBY's Zilebesiran to Enter Phase III After Third Phase II Win

Core Insights - Alnylam Pharmaceuticals and Roche reported positive mid-stage results for zilebesiran in patients with uncontrolled hypertension and high cardiovascular risk [1][5] Group 1: Study Results - The phase II KARDIA-3 study achieved its primary endpoint with a single 300 mg dose of zilebesiran showing placebo-adjusted reductions in office systolic blood pressure at month 3, although it did not meet the pre-specified statistical significance [3][5] - The 300 mg dose also resulted in clinically meaningful reductions in 24-hour mean ambulatory systolic blood pressure at three and six months, with effects sustained throughout the 24-hour cycle [3][6] - Zilebesiran demonstrated early and durable reductions in cardiovascular and renal biomarkers, indicating potential long-term benefits for high-risk populations [7] Group 2: Future Plans - Alnylam and Roche plan to initiate a global phase III cardiovascular outcomes trial, ZENITH, to evaluate zilebesiran's potential to reduce major adverse cardiovascular events [9][11] - The ZENITH study will enroll approximately 11,000 patients and is expected to start by late 2025, focusing on patients with uncontrolled hypertension on multiple antihypertensives [11] Group 3: Market Performance - Year to date, Alnylam's stock has increased by 89.8%, significantly outperforming the industry average growth of 2.7% [4]