Isis Reports Final Phase 2 Data on ISIS-APOCIII Rx in Patients With High Triglycerides and Type 2 Diabetes
"Patients with high levels of triglycerides often have other serious health conditions, including obesity and type 2 diabetes. The significant reductions of both lipid and glucose parameters in patients treated with ISIS-APOCIIIRx in this study suggest that reducing apoC-III could have a significant therapeutic impact on patients who, in addition to severely high triglycerides, also have type 2 diabetes," said
The Phase 2 study of ISIS-APOCIIIRx was a blinded, randomized, placebo-controlled 13-week study designed to assess the safety and activity of 300 mg/week of ISIS-APOCIIIRx in patients with high triglyceride levels (between 200 and 500 mg/dL) and type 2 diabetes with HbA1c levels between 7.0 percent and 9.0 percent. The data presented today are a per protocol analysis of the final data (including treatment and follow up period through Day 176). Isis reported an interim analysis of these data in June 2013. These new data for ISIS-APOCIIIRx will be presented today by Dr.
ISIS-APOCIIIRx was well tolerated in the study with no discontinuations. The most common adverse event was injection site reactions, which were 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, no clinically meaningful changes in other laboratory values and no treatment-related serious adverse events.
"We plan to develop ISIS-APOCIIIRx initially as a therapy for patients with familial chylomicronemia syndrome (FCS), a rare orphan disease in which patients have extremely high triglyceride levels, typically greater than 2,000 mg/dL. We also plan to develop ISIS-APOCIIIRx for use in patients with triglyceride levels greater than 880 mg/dL. Patients with triglyceride levels greater than 880 mg/dL can also have diabetes or metabolic syndrome. For these patients, a drug that significantly lowers triglyceride and apoC-III levels, significantly reduces HbA1c, and demonstrates improvements in glucose control and insulin sensitivity, could provide unique therapeutic value," 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. Humans with elevated levels of apoC-III have high triglycerides 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. Humans with severely elevated triglycerides are at risk of many serious health conditions, including pancreatitis, which can be life-threatening and require hospitalization.
Isis is exploiting its leadership position in antisense technology to discover and develop novel drugs for its product pipeline and for its partners. Isis' broad pipeline consists of 32 drugs to treat a wide variety of diseases with an emphasis on cardiovascular, metabolic, severe and rare diseases, including neurological disorders, and cancer. Isis' partner, Genzyme, is commercializing Isis' lead product, KYNAMRO®, in
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