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Drug Reduces Blood Fat by 64% in Phase II Study
Positive data have been announced from a phase II study of the investigational antisense drug ISIS-APOCIIIRx (Isis Pharmaceuticals) in patients with high to severely high triglyceride levels on stable doses of fibrates.
In the new study, patients treated with the drug experienced reductions of up to 70% in apolipoprotein C-III (apoC-III) and up to 64% percent in triglycerides. In addition, treated patients experienced an increase in high-density lipoprotein cholesterol (HDL-C) — the “good” cholesterol — of up to 52%, and a reduction in apoC-III–associated very-low-density lipoprotein (VLDL) particles of up to 77%.
ISIS-APOCIIIRx is being evaluated in this phase II study as monotherapy in patients with severely high triglycerides. The results will be reported on August 31 at the European Society of Cardiology in Amsterdam.
A total of 26 patients received either ISIS-APOCIIIRx (200 or 300 mg) or placebo via weekly subcutaneous injections. All of the patients were on stable doses of fibrates, with average baseline levels of fasting triglycerides of between 282 mg/dL and 457 mg/dL.
ISIS-APOCIIIRx is an antisense drug designed to treat patients with severely high triglycerides either as a single agent or in combination with other triglyceride-lowering agents. The drug targets apoC-III, a gene produced in the liver that plays a central role in the regulation of serum triglycerides. People 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.
Source: Isis Pharmaceuticals; July 22, 2013.