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Alnylam Initiates KARDIA-1 Phase 2 Study of Zilebesiran (ALN-AGT) in Patients with Mild-to-Moderate Hypertension
– KARDIA-1 will Evaluate Efficacy and Safety of Quarterly and Biannual Regimens of Zilebesiran as Monotherapy – CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Alnylam
About this update from Alnylam Pharmaceuticals, Inc.
[{"type":"text","content":"\n– KARDIA-1 will Evaluate Efficacy and Safety of Quarterly and Biannual Regimens of Zilebesiran as Monotherapy –\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nAlnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced initiation of KARDIA-1, a global Phase 2 study evaluating the efficacy and safety of zilebesiran (pronounced “zile-BEE-siran” and formerly known as ALN-AGT), an investigational subcutaneous RNAi therapeutic targeting liver-expressed angiotensinogen (AGT) in development for the treatment of hypertension. KARDIA-1 will evaluate zilebesiran as monotherapy across different doses administered quarterly and biannually. The Company will host an “RNAi Roundtable” webinar today at 10:00 a.m. ET to discuss the zilebesiran program.\n\nThe primary endpoint of KARDIA-1 is the change from baseline in systolic blood pressure as measured by 24-hour ambulatory blood pressure monitoring after three months of treatment. Additional endpoints will include change from baseline in blood pressure at six months, time-averaged reduction of blood pressure as a measure of tonic control, and safety. The study initiation is based on encouraging Phase 1 data, including results presented earlier this year at the 2021 Joint Meeting of the European Society of Hypertension (ESH) and the International Society of Hypertension (ISH). KARDIA-1 has been activated at clinical sites in the U.S. and will also be conducted at sites in Europe.\n\n“According to the World Health Organization, hypertension is the largest modifiable risk factor for cardiovascular morbidity and mortality. Despite the availability of numerous anti-hypertensive medications, tonic control of blood pressure remains elusive and represents a major unmet need, elevating the risk of fatal and nonfatal cardiovascular events, primarily stroke and heart attack. In addition, lack of patient adherence to therapy with daily oral medications further contributes to the challenges of inadequate blood pressure control,” said Weinong Guo, M.D., Ph.D., Senior Vice President of Clinical Development at Alnylam. “The initiation of KARDIA-1, along with the planned start of the KARDIA-2 Phase 2 study later this year, signifies Alnylam’s commitment to advance zilebesiran as a potential treatment to help address the worldwide burden of uncontrolled hypertension.”\n\nAdd...