Ionis Pharmaceuticals Inc. (IONS) announced positive results from its pivotal Phase 3 CORE and CORE2 studies evaluating olezarsen in patients with severe hypertriglyceridemia (sHTG). The trials successfully met their primary endpoint, with olezarsen achieving a placebo-adjusted mean reduction in fasting triglyceride levels of up to 72% at six months. These reductions were durable, remaining consistent through 12 months of treatment.
In a major clinical milestone, olezarsen demonstrated an 85% reduction in acute pancreatitis events, marking the first and only time such an outcome has been achieved in the sHTG population. Furthermore, 86% of patients treated with olezarsen reached triglyceride levels below 500 mg/dL, a threshold associated with reduced risk of pancreatitis. The therapy also showed a favorable safety and tolerability profile, with no significant safety concerns reported.
A pooled analysis of the number needed to treat (NNT) revealed that treating 20 patients with olezarsen could prevent one acute pancreatitis event over the course of a year. In the highest-risk subgroup—those with triglyceride levels =880 mg/dL and a history of pancreatitis—only four patients would need to be treated to prevent one event annually.
Beyond its impact on triglycerides, olezarsen also improved the overall lipid profile, delivering significant reductions in key secondary endpoints including apoC-III, remnant cholesterol, and non-HDL-C.
Ionis confirmed it is on track to submit a supplemental new drug application (sNDA) to the FDA for both the 50 mg and 80 mg doses by the end of the year. An open-label extension (OLE) study is currently underway, with over 90% of patients from the CORE and CORE2 trials opting to continue treatment in the extension phase.
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