Clinically meaningful pivotal study results for olezarsen in sHTG presented as a late breaker at AHA Scientific Sessions

STOCKHOLM, Nov. 8, 2025 /PRNewswire/ -- Sobi® (STO: SOBI) today announced that, the TIMI Study Group today has presented positive results from the pivotal Phase 3 CORE and CORE2 studies of olezarsen in people with severe hypertriglyceridemia (sHTG) at the American Heart Association 2025 Scientific Sessions. The studies met the primary endpoint, with olezarsen achieving a highly statistically significant placebo-adjusted mean reduction in fasting triglyceride (TG) levels of up to 72% at six months. The reductions were sustained through 12 months.

Up to 72% placebo-adjusted mean reduction in fasting triglyceride levels at six months, with reductions sustained through 12 months 86% of olezarsen-treated patients achieved triglyceride levels less than 500 mg/dL First investigational treatment for sHTG to significantly reduce acute pancreatitis events Data simultaneously published in The New England Journal of Medicine

Olezarsen showed a highly statistically significant 85% reduction in acute pancreatitis events, the first time this has been achieved in sHTG. Additionally, 86% of olezarsen-treated patients achieved triglyceride levels less than 500 mg/dL. Olezarsen demonstrated favorable safety and tolerability.

In CORE and CORE2 43% of patients had extremely high levels of triglycerides ≥880 mg/dL, which is often equated to multifactorial chylomicronemia syndrome (MCS) due to the associated increased accumulation of chylomicrons. The effect on triglyceride-lowering and reduction in acute pancreatitis in the MCS subgroup were in line with the overall population.

These data were presented today during a late-breaking session at the American Heart Association (AHA) Scientific Sessions, taking place November 7-10 in New Orleans, and simultaneously published in The New England Journal of Medicine.

"CORE and CORE2 are the first studies to show a significant reduction in acute pancreatitis events in sHTG, with most patients on olezarsen achieving triglyceride levels below the risk threshold for these potentially life-threatening episodes," said Nicholas Marston, M.D., M.P.H, presenting author, cardiologist, Brigham and Women's Hospital, Harvard Medical School. "As a lipid specialist who takes care of sHTG patients, I have seen the major consequences of acute pancreatitis, including cases with recurrent events requiring frequent hospitalizations. Given the modest effects of conventional therapies, these impactful data are a welcome advance."

"We are highly encouraged by the CORE and CORE2 results showing that olezarsen can help most patients with severe hypertriglyceridemia achieve safer triglyceride levels and significantly reduce their risk of acute pancreatitis," said Lydia Abad-Franch, Head of R&D and Chief Medical Officer of Sobi. "It confirms our belief in the promise of olezarsen in a broader patient group and offers new hope for a tangible improvement in quality of life for those who have long struggled with limited treatment options. Sobi is moving forward with the European submission for olezarsen in MCS which we are planning for next year."

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Nearly 1,100 patients were enrolled in the CORE and CORE2 studies, which is the largest pivotal program ever conducted in sHTG, and patients were required to be on standard of care lipid-lowering therapy. The two phase 3, randomized, double-blind, placebo-controlled CORE and CORE2 trials assessed the impact of olezarsen SC every 4 weeks on fasting plasma TG levels and rates of acute pancreatitis in 617 and 446 patients with severe hypertriglyceridemia (sHTG, fasting plasma TG levels ≥ 500 mg/dL).

The CORE and CORE2 studies met the primary endpoint across doses, with olezarsen demonstrating an up to 72% (p