Isis Pharmaceuticals, Inc. (ISIS) announced positive results from a Phase 1 study with ISIS-ANGPTL3Rx to treat hyperlipidemia.
ISIS-ANGPTL3Rx is one of the drugs in Isis' lipid franchise that its wholly owned subsidiary, Akcea Therapeutics, is developing and plans to commercialize.
ISIS-ANGPTL3Rx is an antisense drug designed to reduce ANGPTL3, which is produced in the liver and regulates lipid, glucose and energy metabolism.
The Phase 1 study of ISIS-ANGPTL3Rx was a blinded, placebo-controlled, dose-escalation study in healthy volunteers that was designed to assess the safety, tolerability and pharmacokinetics of ISIS-ANGPTL3Rx.
ISIS-ANGPTL3Rx was evaluated in single and multiple doses ranging from 50 mg per week up to 400 mg per week for the single dose and 100 mg per week up to 400 mg per week for the multiple dose. In this study, ISIS-ANGPTL3Rx was generally well tolerated.
In the Phase 1 study, healthy volunteers treated with ISIS-ANGPTL3Rx achieved dose-dependent, statistically significant reductions in angiopoietin-like 3 (ANGPTL3) of up to 93 percent with a mean reduction of up to 84 percent from baseline (p<0.001).
Additionally, statistically significant reductions from baseline in lipid parameters were observed, including up to 63% with a mean reduction of up to 49% (p<0.01) in triglycerides and up to 46% with a mean reduction of up to 28% (p<0.001) in total cholesterol.
ANGPTL3 is a protein that acts as a key regulator of these blood lipids. These data were presented at the 83rd European Atherosclerosis Society in Glasgow, United Kingdom.
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