12:00 AM
Jul 01, 2013
 |  BioCentury  |  Product Development


Isis Phase II hints at statin-like efficacy, safety in hypertriglyceridemia

If initial Phase II data bear out in larger trials, Isis Pharmaceuticals Inc. thinks ISIS-APOCIIIRx could alter the treatment landscape for hypertriglyceridemia much like statins did for hypercholesterolemia.

ISIS-APOCIIIRx is an antisense inhibitor of apolipoprotein C-III (APOCIII; APOC3), which regulates triglyceride clearance from blood. Elevated plasma levels of APOC3 are pro-atherogenic and closely correlate with hypertriglyceridemia.

Last week's Phase II results showed weekly subcutaneous injections of ISIS-APOCIIIRx met the primary endpoint of reducing APOC3 levels.

The placebo-controlled study enrolled 11 diabetic patients with moderately high triglycerides (200-500 mg/dL) on stable treatment with metformin. For the seven patients in the treatment group, ISIS-APOCIIIRx reduced triglycerides by 72%, increased HDL-C by 40% and reduced APOC3 by 88% (p<0.03). Importantly, the molecule did not increase LDL-C.

All treated patients reached triglyceride levels less than 100 mg/dL, and mean triglyceride levels were 71 mg/dL at the end of treatment.

The European Atherosclerosis Society (EAS) and European Society of Cardiology (ESC) recommended a goal of fasting triglycerides of less than 150 mg/dL in dyslipidemia treatment guidelines published in Atherosclerosis in 2011.

ISIS-APOCIIIRx also decreased plasma glucose and increased insulin sensitivity. There were no significant adverse events or clinically meaningful elevations in liver enzymes.

Data were presented at the American Diabetes Association meeting in Chicago.

Isis Chairman and CEO Stanley...

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