Date: 2015-07-29
Type of information: Publication of results in a medical journal
phase: 2
Announcement: publication of results in The New English Journal of Medicine
Company: Isis Pharmaceuticals (USA - CA)
Product: volanesorsen (ISIS-APOCIIIRx)
Action
mechanism: antisense oligonucleotide. 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. Volanesorsen is part of Isis\' lipid franchise, which is being developed and commercialized by Akcea Therapeutics.
Disease: patients with high to severely high triglycerides
Therapeutic area: Cardiovascular diseases - Metabolic diseases
Country: Canada, USA
Trial
details: The purpose of this study is to evaluate the dose/response pharmacodynamic effects of ISIS ApoC-III Rx vs. Placebo on fasting total apoC-III levels. (NCT01529424)
Latest
news: * On July 29, 2015, Isis Pharmaceuticals announced that The New England Journal of Medicine (NEJM) has published positive clinical results from a Phase 2 clinical study evaluating volanesorsen (formerly ISIS-APOCIIIRx) in patients with very high to severely high triglycerides. The paper, titled \"Antisense Inhibition of APOC3 in Patients with Hypertriglyceridemia\" (Gaudet et al, N Engl J Med 2015: published online July 29), reported data from the Phase 2 study of volanesorsen, a double-blind, randomized, placebo-controlled 13-week study designed to assess the safety and activity of volanesorsen in patients as a monotherapy and as an add-on to fibrates. Patients treated with volanesorsen achieved mean reductions of up to 80 percent in apoC-III and up to 71 percent in triglycerides and average increases of up to 46 percent in HDL-C. The efficacy, safety and tolerability of volanesorsen in patients with very high to severely high triglycerides to date support continued development.
