Press release
Alnylam Presents New Data for Zilebesiran, an Investigational RNAi Therapeutic for the Treatment of Hypertension, at the American Heart Association Scientific Sessions 2021
– Single Doses of Investigational Zilebesiran Resulted in Sustained Serum Angiotensinogen and Blood Pressure Reductions Through Six Months, Supporting
About this update from Alnylam Pharmaceuticals, Inc.
[{"type":"text","content":"\n– Single Doses of Investigational Zilebesiran Resulted in Sustained Serum Angiotensinogen and Blood Pressure Reductions Through Six Months, Supporting Quarterly and Potentially Biannual Dosing –\n\n– Blood Pressure Response to Low-Salt Intake under the Peak Pharmacodynamic Effect of Zilebesiran was Consistent with Augmented Pharmacology, with No Hypotensive Adverse Events Reported –\n\n– Coadministration with Irbesartan Resulted in Additional Blood Pressure Lowering without Signals of Renal Toxicity –\n\n– Zilebesiran was Generally Well Tolerated, With No Treatment-Related Serious Adverse Events or Study Withdrawals, Supporting Continued Development –\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nAlnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, today announced positive interim results from the ongoing Phase 1 study of zilebesiran (formerly known as ALN-AGT), an investigational subcutaneous RNAi therapeutic targeting liver-expressed angiotensinogen (AGT) in development for the treatment of hypertension. Findings on the pharmacodynamic and antihypertensive effects of zilebesiran six months after a single dose were presented at the American Heart Association (AHA) Scientific Sessions 2021, taking place virtually from November 13-15, 2021. Additional results demonstrated that zilebesiran was safe and well tolerated in the Phase 1 study during salt restriction and when administered concomitantly with irbesartan, an oral renin-angiotensin-aldosterone system inhibitor (RAASi).\n\nIn the Phase 1 study, 84 patients with hypertension were randomized and enrolled in ascending single dose cohorts of zilebesiran up to 800 mg (N=12 per dose cohort; 2:1 randomization of zilebesiran:placebo). As of the May 28, 2021 data cut-off date, patients treated with single doses of zilebesiran at ≥100 mg experienced reductions in serum AGT of ≥90 percent from Week 3 and sustained to Week 12. In the 800 mg dose cohort, durable reductions in serum AGT of >90 percent were maintained through six months. Dose-dependent reductions in blood pressure (BP), assessed by ambulatory blood pressure monitoring (ABPM), were observed in conjunction with AGT knockdown. Mean reductions in 24-hour systolic blood pressure (SBP) of >10 mm Hg were observed at Week 8 after single doses of zilebesiran at ≥200 mg, with clinically meaningful reduct...