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Clinically meaningful pivotal study results for olezarsen in sHTG presented as a late breaker at AHA Scientific Sessions
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
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[{"type":"text","content":"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.","length":556,"tagName":"p"},{"type":"list","items":[{"val":[{"type":"text","content":"Up to 72% placebo-adjusted mean reduction in fasting triglyceride levels at six months, with reductions sustained through 12 months ","length":136,"tagName":"p"}]},{"val":[{"type":"text","content":"86% of olezarsen-treated patients achieved triglyceride levels less than 500 mg/dL ","length":87,"tagName":"p"}]},{"val":[{"type":"text","content":"First investigational treatment for sHTG to significantly reduce acute pancreatitis events ","length":95,"tagName":"p"}]},{"val":[{"type":"text","content":"Data simultaneously published in The New England Journal of Medicine","length":68,"tagName":"p"}]}],"tagName":"ul","bulletedList":true,"length":386,"olType":false},{"type":"text","content":"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.","length":298,"tagName":"p"},{"type":"text","content":"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.","length":356,"tagName":"p"},{"type":"text","content":"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.","length":235,"ta...