Expert Interview
Examining the Phase 3 CORE and CORE2 Study Results for Olezarsen in Severe Hypertriglyceridemia (sHTG) and Familial Chylomicronemia Syndrome (FCS) from Ionis Pharmaceuticals
Ticker(s): IONSA lipidologist or cardiometabolic specialist with expertise in hypertriglyceridemia, pancreatitis prevention, and RNA-targeted therapies. Ideally, the expert should have experience with clinical trials involving triglyceride-lowering therapies and a deep understanding of the unmet needs in patients with sHTG and FCS.
Olezarsen achieved up to a 72% placebo-adjusted reduction in fasting triglycerides at six months in the CORE study. How transformative is this magnitude of reduction for managing high-risk sHTG patients who often present with triglyceride levels exceeding 1,000 mg/dL?
Added By: slingshot_insightsThe studies reported an 85% reduction in acute pancreatitis events, a first for any therapy in sHTG. How might these findings influence current preventive strategies for pancreatitis in both sHTG and FCS populations?
Added By: slingshot_insightsOlezarsen showed a favorable safety profile, with serious adverse events occurring less frequently than placebo and injection-site reactions being the most common event. How does this profile compare to current standard-of-care lipid-lowering therapies and investigational agents?
Added By: slingshot_insightsOlezarsen is already approved as TRYNGOLZA® for familial chylomicronemia syndrome (FCS). Given these new results in a broader sHTG population, how do you see olezarsen’s role evolving between rare genetic cases like FCS and more prevalent sHTG cases?
Added By: slingshot_insightsParticipants were required to remain on standard lipid-lowering therapies during the studies. How do you envision olezarsen fitting into existing treatment regimens — as an add-on therapy or potentially a frontline option for certain high-risk patient groups?
Added By: slingshot_insightsIonis plans to submit a supplemental NDA by the end of the year. Considering the size of the affected U.S. population (~3 million with sHTG) and the high-risk subgroup, how significant could olezarsen’s approval be in reshaping the treatment landscape?
Added By: slingshot_insightsOver 90% of patients chose to continue into the open-label extension. What key outcomes will you be looking for in long-term data to better understand olezarsen’s durability, safety, and real-world applicability?
Added By: slingshot_insightsWith olezarsen’s mechanism targeting apoC-III and demonstrating efficacy in both triglyceride lowering and pancreatitis prevention, could this open doors for investigating its use in broader cardiometabolic conditions beyond sHTG and FCS?
Added By: slingshot_insightsAre You Interested In These Questions?
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