Date: 2014-07-17
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Isis Pharmaceuticals (USA - CA)
Product: ISIS-APO(a) Rx
Action
mechanism: antisense oligonucleotide. ISIS-APO(a)Rx is an antisense drug targeting apolipoprotein(a) for the treatment of atherosclerosis. Based on its substantial experience and expertise in developing drugs to treat a variety of lipid disorders, Isis is currently developing ISIS-APO(a)Rx on its own. Apolipoprotein(a) contributes to the formation of plaque in arteries through its attachment to an LDL-C particle in a complex called Lp(a).
Disease: high lipoprotein(a), or Lp(a)
Therapeutic area: Cardiovascular diseases - Metabolic diseases
Country: Canada, Denmark, Germany, The Netherlands, UK
Trial
details: The purpose is to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ISIS-APO(a)Rx given to patients with high lipoprotein(a) for 12 weeks. (NCT02160899)
Latest
news: * On July 17, 2014, Isis Pharmaceuticals announced the initiation of a Phase 2 study evaluating ISIS-APO(a)Rx in patients with high lipoprotein(a), or Lp(a), an independent risk factor for cardiovascular disease. Patients with high levels of Lp(a) have an increased risk of atherosclerosis, coronary heart disease, aortic stenosis, heart attack and stroke. ISIS-APO(a)Rx is designed to reduce Lp(a) by inhibiting the production of apolipoprotein(a). Isis plans to develop ISIS-APO(a)Rx to treat patients with high Lp(a) levels who are at high risk of experiencing life-threatening cardiovascular events. The Phase 2 study is a randomized, placebo-controlled, dose-titration study evaluating the safety and efficacy of ISIS-APO(a)Rx. The 12 week study will evaluate 100 mg, 200 mg and 300 mg doses of ISIS-APO(a)Rx in approximately 60 patients with Lp(a) levels of 50 mg/dL or greater.
