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Alnylam Reports Positive Interim Results from Ongoing Phase 1 Study of ALN-AGT, an Investigational RNAi Therapeutic for the Treatment of Hypertension
− Patients Receiving Investigational ALN-AGT Experienced Dose-Dependent Reductions in Blood Pressure, Confirming Potential for RNAi-Mediated Angiotensinogen
About this update from Alnylam Pharmaceuticals, Inc.
[{"type":"text","content":"\n− Patients Receiving Investigational ALN-AGT Experienced Dose-Dependent Reductions in Blood Pressure, Confirming Potential for RNAi-Mediated Angiotensinogen (AGT) Silencing as a Novel Therapeutic Approach for Hypertension –\n\n− Durable AGT Knockdown Through 12 Weeks Supports a Once Quarterly or Potentially Less Frequent Dosing Regimen –\n\n− ALN-AGT Generally Well Tolerated, with No Treatment-Related Serious Adverse Events or Study Discontinuations –\n\n CAMBRIDGE, Mass.--(BUSINESS WIRE)--\nAlnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today positive interim data from the ongoing Phase 1 study of ALN-AGT, a subcutaneous investigational RNAi therapeutic targeting liver-expressed angiotensinogen (AGT) for the treatment of hypertension. Results were presented in a poster presentation at the American Heart Association (AHA) Scientific Sessions 2020, taking place virtually from November 13 – 17, 2020.\n\nData presented at the AHA Scientific Sessions are from the ongoing Phase 1 study of ALN-AGT with a data cut-off date of September 16, 2020. The study is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) study, evaluating the safety, tolerability and preliminary pharmacokinetic and pharmacodynamic activity of ALN-AGT in patients with mild or moderate hypertension, who were either treatment naïve or had discontinued other anti-hypertensive medications. Patients (N=60) had a mean age of 52 years (range 35 – 65) and a mean baseline 24-hour systolic blood pressure (SBP) and diastolic blood pressure (DBP) of 139 (standard deviation [SD] +/- 8) millimeters of mercury (mm Hg) and 86 (SD +/- 7) mm Hg, respectively. Patients were enrolled in ascending dose cohorts of 10 mg, 25 mg, 50 mg, 100 mg or 200 mg ALN-AGT (N=12 per cohort; 2:1 randomization of ALN-AGT:placebo).\n\nCompared to placebo, patients treated with ALN-AGT experienced dose-dependent reductions in serum AGT — the sole precursor of all angiotensin peptides, including the potent vasoconstrictor angiotensin (Ang) II. In the 200 mg dose cohort, the mean reduction (+/- standard error [SE]) of AGT at 8 weeks was 94.9 +/- 1.6 percent. Reductions of more than 90 percent persisting through 12 weeks after single doses of 100 or 200 mg were observed, with up to 97.6 percent AGT knockdown at 200 mg. The durability ...