Isis Pharmaceuticals has initiated a Phase II study of ISIS 301012 in combination with a statin in patients with high cholesterol. The study is part of a broad Phase II development program of ISIS 301012, a second-generation antisense drug. ISIS 301012 selectively reduces apoB-100, a target critical to the synthesis and transport of the "bad" cholesterol involved in heart disease - low-density lipoprotein cholesterol and very low-density lipoprotein. Lowering cholesterol levels is a key component in the prevention and management of cardiovascular disease.
The study is designed to evaluate the safety and efficacy of ISIS 301012 in patients on stable simvastatin therapy, who are not achieving their cholesterol targets. In the study, patients will be dosed with either 30 mg, 100 mg or 200 mg of ISIS 301012 over a five-week treatment period followed by an eight-week post-treatment evaluation period. In support of the combination study, Isis completed a drug interaction study of ISIS 301012 administered with statins in healthy volunteers. This study supports the ability to dose ISIS 301012 in combination with statins without negative drug interaction.