ISIS 301012 is a second-generation antisense drug that targets apoB-100, the protein component of low density lipoprotein (LDL, or “bad”) cholesterol. Lowering cholesterol levels is key to the management of cardiovascular disease.
The initial study in the phase II development program is designed to optimize dose and frequency of dosing of ISIS 301012 in patients with high cholesterol. The study will also allow Isis to further evaluate the safety and efficacy of ISIS 301012 in patients with high cholesterol.
In the placebo-controlled study, patients will be dosed from 50mg to 200mg per week for three months and will be followed for an additional six months.
“The rapid, significant reduction of apoB-100, total cholesterol, and LDL-C, the bad cholesterol, we saw in our initial study of ISIS 301012 in subjects with mildly elevated cholesterol was impressive, and we are excited to continue to study the drug in patients with high cholesterol,” said Dr Mark Wedel, vice president of clinical research and chief medical officer of Isis Pharmaceuticals. “This study will help us to further optimize the dose and treatment regimen of ISIS 301012 and to evaluate longer-term dosing.”