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Isis Reports Phase 2 Data on ISIS-APOCIII Rx Showing Significant Reductions in Triglycerides and APOC-III in Patients with High Triglycerides and Type 2 Diabetes
Date:6/23/2013

ilable triglyceride-lowering therapies, including diet, ISIS-APOCIIIRx did not raise LDL-C in these patients. There is no other drug in development that demonstrates the potential for such a broad therapeutic profile. The dramatic effect of ISIS-APOCIIIRx on all of these parameters could translate into significant benefit to many patients, including patients with high triglycerides and type 2 diabetes."

The Phase 2 study of ISIS-APOCIII­Rx was a blinded, randomized, placebo-controlled 13-week study designed to assess the safety and activity of ISIS-APOCIIIRx in patients with high triglycerides levels (between 200 and 500 mg/dL) and type 2 diabetes. After only 13 weeks of dosing, robust and prolonged, statistically significant mean reductions of 88 percent from baseline in apoC-III levels (p<0.03) and 72 percent from baseline in fasting plasma triglyceride levels (p<0.03) were observed.  All treated patients achieved triglyceride levels of less than 100 mg/dL by four weeks of dosing, and the average triglyceride level was 71 mg/dL at the end of treatment. Furthermore, patients treated with ISIS-APOCIIIRx demonstrated a rapid, prolonged and statistically significant mean increase in HDL-C of 40 percent from baseline (p<0.03) with improvements in overall lipid parameters, including non-HDL-C and VLDL-C, and no increase in LDL-C. 

In addition, consistent improvements in HbA1c and other measures of glucose control, including serum fructosamine and glycated albumin, were observed in patients dosed with ISIS-APOCIIIRx. The effects of ISIS-APOCIIIRx observed on measures of glucose control were in addition to those achieved with each patient's existing therapeutic regimen of metformin.  Improvements in indicators of insulin sensitivity were also observed in patients suggesting that inhibition of apoC-III could improve insulin sensitivity in patients w
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SOURCE Isis Pharmaceuticals, Inc.
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