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Isis Reports Interim Phase 2 Data on ISIS-APOCIII Rx as a Single Agent in Patients With Very High to Severely High Triglycerides
Date:8/31/2013

. placebo *Interim analysisIn the ongoing study, patients received 100 mg, 200 mg or 300 mg dose of ISIS-APOCIIIRx, or placebo via weekly subcutaneous injections.  In this interim analysis, patients had an average fasting triglyceride level of 602 mg/dL with incoming triglyceride levels up to 1,822 mg/dL.  In this study ISIS-APOCIIIRx was found to be generally safe and well tolerated.  The most common adverse event (AE) was injection site reactions, which were infrequent, predominantly mild and typically resolved rapidly.  There were no flu-like symptoms, no treatment-related elevations of liver enzymes greater than three times upper limit of normal, no abnormalities in renal function and no clinically meaningful changes in other laboratory values. 

"We are pleased with the performance of ISIS-APOCIIIRx to date. We have now demonstrated that ISIS-APOCIIIRx is equally effective in patients with high to severely high triglycerides as well as in patients with high triglycerides and type 2 diabetes.  We have demonstrated that ISIS-APOCIIIRx can work equally well as a single agent and in combination with fibrates to produce significant reductions in apoC-III and triglycerides, and increases in HDL-C.  In addition, the positive effect of ISIS-APOCIIIRx treatment on lipid parameters, improvements in glucose control and trends toward improvements in insulin sensitivity, suggest that ISIS-APOCIIIRx could have a very attractive therapeutic profile for patients with severely high triglycerides, who often also have diabetes or metabolic syndrome," said Richard Geary, Ph.D., senior vice president of development at Isis.  "We look forward to discussing our Phase 3 plans with regulators and moving rapidly into a Phase 3 program next year in patients with severely high triglycerides."

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SOURCE Isis Pharmaceuticals, Inc.
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