Date: 2014-05-02
Type of information: Results
phase: 2
Announcement: results
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.
Disease: patients with high triglycerides and type 2 diabetes
Therapeutic area: Cardiovascular diseases - Metabolic diseases
Country:
Trial
details: 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.
Latest
news: * On May 2, 2014, Isis Pharmaceuticals has announced the final results from its Phase 2 study of ISIS-APOCIIIRx in patients with high triglycerides and type 2 diabetes. In this study, patients treated with ISIS-APOCIIIRx achieved statistically significant average mean percent reduction from baseline of 88 percent (p=0.02) in apolipoprotein C-III (apoC-III) and 69 percent (p=0.02) in triglycerides, and an average mean percent increase of 42 percent (p=0.03) in high-density lipoprotein cholesterol (HDL-C) after 13 weeks of dosing. All treated patients achieved triglyceride levels of less than 104 mg/dL and averaged triglyceride levels under 76 mg/dL by four weeks, and the average triglyceride level was maintained under 76 mg/dL until the end of treatment (a normal triglyceride level is 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. Isis Pharmanaceuticals plans to initiate Phase 3 studies for ISIS-APOCIIIRx this year.
