Sobi has touted new efficacy results for Tryngolza (olezarsen) in severe hypertriglyceridemia, as the company and its commercial partner, Ionis Pharmaceuticals, gear up for the drug’s potential launch in the indication.
Through a pooled subgroup analysis, which factored in results from the Phase III CORE and CORE2 studies (NCT05079919; NCT05552326), Sobi found that patients with triglyceride levels of 10 mmol/L or more taking an 80mg, four-weekly dose of Tryngolza experienced a 66% placebo-adjusted drop in blood levels of the fatty acid at the six-month mark.
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Meanwhile, those on Tryngolza 50mg saw a 59% reduction. Overall, 85% of patients treated with Tryngolza achieved triglyceride levels lower than 10 mmol/L – a cutoff point in which the European Atherosclerosis Society (EAS) recommends that patients receive urgent, triglyceride-lowering treatment to diminish their risk of developing acute pancreatitis.
Patients with blood triglyceride levels of 10 mmol/L or more are four times more likely to develop acute pancreatitis compared to patients with ideal blood concentrations. Sobi’s chief medical officer, Lydia Abad-Franch, notes that the CORE findings highlight Tryngolza’s potential as an “important part of a preventative approach to disease management in at-risk patients.”
These results, presented as a late-breaking abstract at the 2026 EAS congress, come as acute pancreatitis cases continue to burden healthcare systems worldwide. According to an epidemiological study published in BMC Gastroenterology, global cases saw a 59% uptick between 1990 and 2021, with deaths from the condition soaring 78.7% in this timeframe.
Reinvigorating the severe hypertriglyceridemia market
Results of Sobi’s pooled subgroup analysis come as the Swedish pharma company and the drug’s original developer, Ionis, await the verdicts of US and European regulatory bodies on Tryngolza in severe hypertriglyceridemia, as the companies look to expand the drug’s use to a broader patient population. The US Food and Drug Administration (FDA) has a target action date of 30 June.
Ionis retains commercial rights to the drug in the US, while Sobi holds rights outside the US, apart from Canada and China. Neither company disclosed the financials of their partnership.
Currently, Tryngolza is approved in both the US and European markets for the treatment of familial chylomicronaemia syndrome (FCS) – a rare genetic disorder driven by high blood triglyceride levels.
However, Sobi and Ionis are not alone in their goal of breaking onto the severe hypertriglyceridemia market, as Arrowhead Pharmaceuticals is also running late-stage studies on its small interfering RNA (siRNA)-based triglyceride-lowering therapy, Redemplo (plozasiran). Like Tryngolza, Redemplo is approved in FCS.
In a recent research note, Jefferies analysts praised Redemplo’s recent launch in FCS, which they say was “trending better” versus Tryngolza at a similar timepoint – potentially indicating the future dynamics in the severe hypertriglyceridemia market.
Currently, GlobalData predicts a blockbuster future for both Tryngolza and Redemplo, with consensus forecast estimating that the drugs will reach this status by 2029 and 2031, respectively.
GlobalData is the parent company of Clinical Trials Arena.
