Alnylam Presents Positive Late-Breaking Data from Ongoing Phase 1 Study of ALN-AGT, an Investigational RNAi Therapeutic for the Treatment of Hypertension
Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today positive interim results 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 during a late-breaking oral presentation at the 2021 Joint Meeting of the European Society of Hypertension (ESH) and the International Society of Hypertension (ISH). ALN-AGT treatment was associated with dose-dependent knockdown of AGT and reductions in blood pressure (BP) with a durability that supports the potential for a once quarterly or biannual dosing regimen, and was found to be generally safe and well tolerated.
“We face an intractable challenge in controlling hypertension, which affects an estimated 1.13 billion people worldwide and is a major risk factor for cardiovascular disease morbidity and premature mortality.i Despite well-established treatments including lifestyle modifications and several classes of available anti-hypertensive medications, fewer than 20 percent of people with hypertension globally have it under control,”i said Reinhold Kreutz, M.D., Ph.D., Professor, Charité and Berlin Institute of Health, Institute of Clinical Pharmacology and Toxicology and President, ESH. “While several factors contribute to the high rate of uncontrolled hypertension, inconsistent blood pressure control and medication adherence in those patients receiving treatment may play critical roles, and the encouraging early-stage results for ALN-AGT suggest its potential as a novel therapeutic approach to address long-standing treatment gaps.”
Eighty-four patients with hypertension were randomized in this double-blind, placebo-controlled, single ascending dose (SAD) study evaluating the safety, tolerability and preliminary pharmacokinetic and pharmacodynamic activity of ALN-AGT. Patients, who were either treatment naïve or had discontinued other anti-hypertensive medications prior to study entry, enrolled in ascending dose cohorts of 10 mg, 25 mg, 50 mg, 100 mg, 200 mg, 400 mg or 800 mg ALN-AGT.
Patients treated with single doses of ALN-AGT at 100 mg or higher experienced durable reductions in serum AGT of more than 90 percent through 12 weeks. In the 800 mg dose cohort, all patients experienced reductions in serum AGT of 96 – 98 percent at Week 12. Concomitant reductions in BP were observed with AGT knockdown, with clinically meaningful mean reductions in 24-hour systolic blood pressure (SBP) of >10 mm Hg observed at Week 8 after single doses of 100 mg or higher. At 800 mg, mean reductions in 24-hour SBP of 17 mm Hg were observed at Week 8 (compared to a mean increase of 1 mm Hg in the placebo group) and sustained through Week 12. All data are as of a February 25, 2021 cut-off date.
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