Ionis Pharmaceuticals has commenced the Phase III CORE clinical trial of investigational antisense medicine, olezarsen, in patients with severe hypertriglyceridemia.
Formerly called IONIS-APOCIII-LRx, Olezarsen uses Ionis’ LIgand-Conjugated Antisense technology and hinders the apoC-III production for patients at risk of cardiometabolic disease and acute pancreatitis due to an increase in triglyceride levels.
Ionis Pharmaceuticals clinical development senior vice-president and cardiovascular franchise leader Sotirios Tsimikas said: “Severe hypertriglyceridemia is a common condition that affects millions of people around the world, including more than three million in the US.
“Initiating the CORE study is a major step in realising the full potential of olezarsen to treat the range of conditions related to elevated triglycerides associated with high levels of the apoC-llI protein.”
The global, randomised, double-blind, registrational, and placebo-controlled Phase III study will assess the efficacy of olezarsen compared to placebo in patients with triglyceride levels greater than or equal to 500mg/dL.
In this trial, approximately 450 participants will be randomised and given olezarsen or placebo in a treatment period for 53 weeks.
The percentage change from baseline in fasting triglycerides at month six is the trial’s primary endpoint.
Meanwhile, the secondary goals include the per cent change in fasting triglycerides from baseline at 12 months and other atherogenic lipids from baseline at six and 12 months.
Adjudicated acute pancreatitis event rates during the treatment period, as well as the proportion of patients who achieve fasting triglycerides that are less than 500 mg/dL, 880mg/dL and/or 1,000mg/dL will also form the secondary endpoints of the trial.
The company stated that the medicine has met both the endpoints with significant reductions in the levels of apoC-III and triglyceride in a Phase II clinical trial.
Additionally, olezarsen showed a favourable tolerability and safety profile in patients’ treatment with hypertriglyceridemia (≥200mg/dL to ≤500mg/dL) who have cardiovascular disease or are at risk for it.
Severe hypertriglyceridemia is associated with high ApoC-III and chylomicronemia levels, which lead to a higher risk of cardiovascular disease.