ISIS-APOCIIIRx Shows Positive Results In Phase-2

(RTTNews) - Isis Pharmaceuticals, Inc. (ISIS) said its investigational drug ISIS-APOCIIIRx showed positive results in a mid-stage study in patients with high to severely high triglyceride levels on stable doses of fibrates. The drug candidate produced statistically significant reductions of Triglycerides, ApoC-III and ApoC-III Associated VLDL or very low-density lipoprotein particles and was found to be be generally safe and well tolerated.

ISIS-APOCIIIRx is an antisense drug intended to treat patients with severely high triglycerides either as a single agent or in combination with other triglyceride-lowering agents.

The double-blind, randomized, placebo-controlled 13 week study was designed to assess the safety and activity of 200 mg and 300 mg doses of ISIS-APOCIIIRx. 28 patients received either 200 mg or 300 mg dose of ISIS-APOCIIIRx or placebo via weekly subcutaneous injections.

In this study, patients treated with ISIS-APOCIIIRx achieved average reductions of up to 71 percent in apolipoprotein C-III and up to 64 percent in triglycerides, and average increases of up to 52 percent in high-density lipoprotein cholesterol HDL-C, or the 'good cholesterol'.

The phase two study showed that the investigational drug lowered triglycerides equally well in patients with high to severely high triglycerides as well as in patients with high triglycerides and type 2 diabetes.

The company is looking forward to advance ISIS-APOCIIIRx into Phase 3 clinical studies this year.