Isis drug lowers cholesterol associated with heart disease

The phase I study demonstrated the ability of ISIS 301012 to produce rapid reductions of its target, apoB-100, with concomitant reductions in low density lipoprotein (LDL or “bad” cholesterol). These results support the company’s previous study in which the treatment produced rapid, dose-dependent, and prolonged reductions of apoB-100 and LDL.

The data shows that less than one month following dosing, healthy volunteers achieved a median reduction of 60% in apoB-100 and a median reduction of 54% in LDL.

In the study, six healthy volunteers with mildly elevated cholesterol levels were treated with approximately 350 mg/week of ISIS 301012 for one month. No treatment-related serious adverse events were reported.

“With statin-like lipid reductions via a non-statin mechanism, ISIS 301012’s attractive profile continues to show significant promise as an alternative for patients who are not tolerating statin therapy or as add-on therapy for the lowering of cholesterol in patients failing to reach their therapeutic target,” said Dr Wedel, vice president of clinical research and chief medical officer at Isis Pharmaceuticals.

Dr Wedel said he believes the treatment, “has the potential to address a substantial market opportunity since cardiovascular disease is one of the leading causes of death in the world.”

Isis plans to commence a series of phase II trials in the second-half of 2005 to optimize dose and schedule of ISIS 301012 as monotherapy, to explore pharmacology in combination with statins and to study the effects of ISIS 301012 in patients with familial hypercholesterolemia.

An oral formulation of ISIS 301012 is currently in phase I studies. Isis plans to report data from the oral study in the second half of 2005.