Isis Pharmaceuticals starts ISIS-APOARx Phase 1 clinical study for treatment of atherosclerosis

Isis Pharmaceuticals, Inc. (NASDAQ: ISIS) announced today that it has initiated a Phase 1 clinical study for ISIS-APOA_Rx, an antisense drug targeting apolipoprotein(a) for the treatment of atherosclerosis. Apolipoprotein(a) contributes to the formation of plaque in arteries through its attachment to an LDL-C particle in a complex termed lipoprotein(a), or Lp(a).  High levels of Lp(a) are associated with an increased risk of atherosclerosis, coronary heart disease, heart attack and stroke. ISIS-APOA_Rx is designed to reduce Lp(a) by inhibiting the production of apolipoprotein(a). Isis plans to develop ISIS-APOA_Rx to treat patients with high Lp(a) levels who are at high risk of experiencing cardiovascular events.

"Lp(a) is an independent risk factor for coronary heart disease. Although Lp(a) can be measured during a routine lipid blood panel, the lack of drugs that effectively lower Lp(a) have made treating patients with high Lp(a) levels difficult. Because elevated Lp(a) is an inherited genetic condition, patients are unable to adequately control their Lp(a) levels through diet or lifestyle changes.  By inhibiting the production of apolipoprotein(a), ISIS-APOA_Rx is designed to reduce the levels of Lp(a), thereby offering a unique and specific approach to treating patients who have high cardiovascular risk due to high Lp(a) levels," said Walter Singleton, M.D., vice president of development and chief medical officer at Isis. "ISIS-APOA_Rx is part of Isis' strategy to create a cardiovascular disease franchise comprised of drugs that target all the key components of cardiovascular disease, including various atherogenic lipids, inflammation and thrombosis."

The Phase 1 study of ISIS-APOA_Rx is a blinded, placebo-controlled, dose-escalation study in approximately 56 healthy volunteers. The study is designed to assess the safety, tolerability and pharmacokinetics of both single and multiple doses of ISIS-APOA_Rx.