Clinical Trials

Date: 2018-01-05

Type of information: Initiation of the trial

phase: 2b

Announcement: initiation of the trial

Company: Akcea Therapeutics (USA - CA), a subsidiary of Ionis Pharmaceuticals (USA - CA)

Product: ISIS 678354 (AKCEA-APOCIII-LRx)

Action mechanism:

  • antisense oligonucleotide/antisense drug.
  • AKCEA-APOCIII-LRx is an antisense drug that uses Ionis’ advanced LIgand Conjugated Antisense (LICA) technology, is designed to reduce the production of apolipoprotein C-III, or apoC-III. Elevated levels of apoC-III correlate with high triglyceride levels and have been associated with metabolic abnormalities and premature cardiovascular disease.
  • AKCEA-APOCIII-LRx is part of a strategic collaboration with Novartis to develop and co-commercialize AKCEA-APO(a)-LRx and AKCEA-APOCIII-LRx. Under the terms of the collaboration, if Novartis exercises its option after successful completion of the Phase 2 study, it will be responsible for a global Phase 3 cardiovascular outcome study as well as worldwide development and, if approved, global co-commercialization activities.  

Disease: patients with hypertriglyceridemia and established cardiovascular disease

Therapeutic area: Cardiovascular diseases


Trial details:

  • This is a multicenter, randomized, double-blind, placebo-controlled, dose-ranging study to evaluate the safety, including tolerability, of ISIS 678354 and to assess the efficacy of different doses and dosing regimens of ISIS 678354 for reduction of serum triglyceride (TG) levels in patients with hypertriglyceridemia and established CVD. (NCT03385239)

Latest news:

  • • On January 5, 2018, Akcea Therapeutics, an affiliate of Ionis Pharmaceuticals, focused on developing and commercializing drugs to treat patients with serious cardiometabolic diseases caused by lipid disorders, announced the initiation of a Phase 2b clinical study of AKCEA-APOCIII-LRx in patients with hypertriglyceridemia and established cardiovascular disease (CVD). The study will evaluate the safety and efficacy of different doses and dosing frequencies of AKCEA-APOCIII-LRx in this patient population and provide valuable information for a potential Phase 3 cardiovascular outcomes study. Akcea anticipates reporting top-line data from this study in 2019.

Is general: Yes