|View printer-friendly version|
|Isis Pharmaceuticals Reports Fifth Positive Phase 2 Data Set for ISIS-APOCIII Rx Showing Significant Reductions in Triglyceride and ApoC-III Levels|
"Patients with extremely high levels of triglycerides are at significant risk of many serious health conditions, including frequent episodes of pancreatitis, which can be life-threatening and require hospitalization. Although the benefits of lowering triglycerides in these patients are well established, many of these patients are unable to reduce their triglycerides to acceptable levels. ApoC-III is an important regulator of triglycerides in the blood. As such, a drug targeted to reduce ApoC-III should have a profound and positive effect on triglyceride levels," said
The monotherapy portion of the Phase 2 study of ISIS-APOCIIIRx is a double-blind, randomized, placebo-controlled 13-week study designed to assess the safety and activity of ISIS-APOCIIIRx in patients with very high to severely high triglyceride levels (between 440 and 2,000 mg/dL). In this study, patients received 100 mg, 200 mg or 300 mg dose of ISIS-APOCIIIRx, or placebo via weekly subcutaneous injections for 13 weeks. Patients treated with 300 mg ISIS-APOCIIIRx experienced dose-dependent, robust, prolonged and statistically significant mean reductions in apoC-III, triglycerides and apoC-III-associated VLDL particles of 80, 71 and 88 percent from baseline, respectively. Furthermore, these patients demonstrated a statistically significant mean increase of 46 percent from baseline in HDL-C. 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 have now demonstrated that ISIS-APOCIIIRx has the ability to lower triglycerides equally well 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 observed 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
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. ISIS-APOCIIIRx targets apoC-III, a protein produced in the liver that plays a central role in the regulation of serum triglycerides. Humans who do not produce apoC-III have lower levels of triglycerides and lower instances of cardiovascular disease. In clinical studies, patients with lower levels of apoC-III and triglycerides exhibit lower cardiovascular event rates. Humans with elevated levels of apoC-III have increased dyslipidemia associated with multiple metabolic abnormalities, such as insulin resistance and/or metabolic syndrome. In addition, the prevalence of type 2 diabetes is increased in patients with elevated triglycerides.
In this press release, unless the context requires otherwise, "Isis," "Company," "we," "our," and "us" refers to
Isis Pharmaceuticals® is a registered trademark of
D. Wade Walke, Ph.D., Vice President, Corporate Communications and Investor Relations, 760-603-2741, or Amy Blackley, Ph.D., Associate Director, Corporate Communications, 760-603-2772