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Isis Reports Phase 2 Data on ISIS-APOCIII Rx Showing Significant Reductions of ApoC-III and Triglycerides in Patients With High Triglycerides Taking Fibrates
Date:7/22/2013

es, rapid, robust reductions in apoC-III and triglycerides were observed.  The positive effect of ISIS-APOCIIIRx on other key lipid parameters demonstrates the potential for ISIS-APOCIIIRx to provide therapeutic benefit to patients with very high triglycerides."

In this study, 26 patients received either 200 mg or 300 mg dose of ISIS-APOCIIIRx, or placebo via weekly subcutaneous injections.  All patients were on stable doses of fibrates with average baseline levels of fasting triglycerides between 282 mg/dL and 457 mg/dL.  The three groups of patients were reasonably well balanced in baseline characteristic. 

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 and consisted of mild erythema that typically resolved within one to two days.
There were no flu-like symptoms, no 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.  There was one patient who, four days after treatment, experienced a transient episode of a rash, low-grade fever, chills and headache, which resolved completely. This event was reported by the investigator as related to treatment, and classified as a serum sickness-like reaction (a serious AE). Subsequent detailed investigations demonstrated that it was not serum sickness.

"We are very encouraged by the two sets of positive data we have reported this summer demonstrating that treatment with ISIS-APOCIIIRx produced highly statistically significant and clinically meaningful reductions in apoC-III and triglycerides, and increases in HDL-C in patients with high triglycerides.  In addition, the positive effect of ISIS-APOCIIIRx treatment on lipid parameters, improvements in glucose control a
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SOURCE Isis Pharmaceuticals, Inc.
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