Sobi has announced results from a new analysis of the pivotal phase 3 trials, showing Tryngolza® (olezarsen) reduced the relative risk of acute pancreatitis events by 85% (P<0.001) and reduced triglycerides by 66% in patients with severe hypertriglyceridemia (sHTG) after six months.
The pooled subgroup analysis, presented as a late breaking abstract at the European Atherosclerosis Society (EAS) 2026 Congress in Athens, Greece, included 455 patients with baseline triglycerides of ≥880 mg/dL (~10 mmol/L), defined by the EAS as severe hypertriglyceridemia.
At six months, patients randomised to receive olezarsen 80 mg showed a placebo-adjusted reduction in triglycerides of 66%, and those on olezarsen 50 mg a 59% reduction (each P<0.001). Overall, 85% of olezarsen-treated patients achieved triglycerides of <10 mmol/L.1
Severe hypertriglyceridemia is the third most common cause of acute pancreatitis.[4] The incidence of acute pancreatitis globally has increased at an average annual rate of 3% since the 1960s, contributing to a growing burden on healthcare systems.
The results, presented by Dr Andre Zimerman on behalf of the TIMI Study Group, showed olezarsen 80 mg and 50 mg also reduced remnant cholesterol by 64% and 53%, respectively, and non-HDL-C by 35% and 27%.
The absolute reduction in pancreatitis events with olezarsen was 12 per 100 patient-years, meaning treating nine patients over one year would prevent one acute pancreatitis event in the type of patients included in the study. The safety profile in the subgroup analysis was favourable and similar to the broader trial population.1
In March 2026, the European Medicines Agency validated an indication extension application for olezarsen for the treatment of adults with sHTG and triglyceride levels ≥880 mg/dL (~10 mmol/L), aligned with EAS guidelines.
In February 2026 the US FDA accepted for Priority Review a supplemental New Drug Application for olezarsen for sHTG (triglyceride levels ≥500 mg/dL), with a target action date of June 30, 2026.
Olezarsen is developed by Ionis Pharmaceuticals. Sobi and Ionis entered into a licence agreement under which Sobi has exclusive rights to commercialise Tryngolza in non-US geographies except Canada and China.
