Stockholm, Sweden & Carlsbad, California – [Date of Publication] – In a significant development poised to reshape the landscape of severe hypertriglyceridemia treatment, Swedish biopharmaceutical company Sobi, in collaboration with its commercial partner Ionis Pharmaceuticals, has unveiled compelling new efficacy data for its triglyceride-lowering therapy, Tryngolza (olezarsen). These results, derived from a pivotal Phase III program, demonstrate a substantial reduction in triglyceride levels and a notable decrease in the risk of acute pancreatitis, a potentially life-threatening complication associated with severe hypertriglyceridemia. The findings are particularly noteworthy as they position Tryngolza as a formidable contender against Arrowhead Pharmaceuticals’ Redemplo (plozasiran) in what is shaping up to be a keenly watched rivalry for market dominance.
The latest data, presented as a late-breaking abstract at the prestigious 2026 European Atherosclerosis Society (EAS) Congress, stems from a pooled subgroup analysis of the Phase III CORE and CORE2 studies (NCT05079919; NCT05552326). This analysis focused on patients with severely elevated triglyceride levels, defined as 10 mmol/L or higher. At the six-month mark, patients receiving a 4-weekly, 80mg dose of Tryngolza experienced an impressive 66% placebo-adjusted reduction in their blood triglyceride levels. A slightly lower, yet still significant, 59% reduction was observed in patients treated with a 50mg dose of the therapy.
Crucially, the study revealed that an overwhelming 85% of patients treated with Tryngolza achieved triglyceride levels below the 10 mmol/L threshold. This benchmark is considered critical by the European Atherosclerosis Society (EAS), which recommends urgent triglyceride-lowering intervention for patients at or above this level to mitigate the severe risk of developing acute pancreatitis.
The Devastating Impact of Severe Hypertriglyceridemia and the Role of Tryngolza
Severe hypertriglyceridemia, characterized by abnormally high levels of triglycerides in the blood, is a serious metabolic disorder that significantly elevates the risk of cardiovascular events and, most acutely, acute pancreatitis. Patients with triglyceride levels of 10 mmol/L or more are estimated to be four times more likely to experience an episode of acute pancreatitis compared to individuals with optimal blood concentrations. The condition places a substantial burden on healthcare systems globally, with recent epidemiological studies highlighting a concerning rise in both cases and mortality.
A comprehensive epidemiological study published in BMC Gastroenterology revealed a staggering 59% increase in global acute pancreatitis cases between 1990 and 2021. This surge was accompanied by an alarming 78.7% rise in deaths attributed to the condition during the same period, underscoring the urgent need for more effective therapeutic interventions.
Dr. Lydia Abad-Franch, Sobi’s Chief Medical Officer, emphasized the clinical significance of these findings. "The results from our CORE program highlight Tryngolza’s potential as an important part of a preventative approach to disease management in at-risk patients," she stated. "By significantly reducing triglyceride levels and, by extension, the risk of acute pancreatitis, Tryngolza offers a much-needed therapeutic option for individuals grappling with severe hypertriglyceridemia."
Regulatory Milestones and Market Expansion on the Horizon
The unveiling of these promising efficacy data comes at a critical juncture for Sobi and Ionis. Both companies are eagerly awaiting regulatory decisions from the US Food and Drug Administration (FDA) and European regulatory bodies on Tryngolza for the indication of severe hypertriglyceridemia. The FDA has set a target action date of June 30th for its review, marking a significant milestone in the potential commercialization of the drug for a broader patient population.
Currently, Tryngolza holds approvals in both the US and European markets for the treatment of familial chylomicronaemia syndrome (FCS), a rare genetic disorder characterized by extremely high triglyceride levels. The expansion into the more prevalent severe hypertriglyceridemia market represents a substantial growth opportunity for the drug and its developers.
Under their partnership agreement, Ionis retains commercial rights to Tryngolza in the United States, while Sobi holds these rights in all other global markets, excluding Canada and China. The financial terms of their collaboration have not been publicly disclosed.
The Emerging Rivalry: Tryngolza vs. Redemplo
The severe hypertriglyceridemia market is not without its formidable competitors. Arrowhead Pharmaceuticals is also making significant strides with its small interfering RNA (siRNA)-based therapy, Redemplo (plozasiran). Like Tryngolza, Redemplo is already approved for the treatment of FCS, and Arrowhead is actively conducting late-stage studies to evaluate its efficacy in severe hypertriglyceridemia.
The potential rivalry between Tryngolza and Redemplo is a key focus for market analysts. In a recent research note, Jefferies analysts highlighted Redemplo’s recent launch in FCS, observing that its initial performance was "trending better" compared to Tryngolza at a similar stage of development. This observation has led to speculation about the potential future dynamics and market positioning of both therapies in the broader severe hypertriglyceridemia indication.
GlobalData, a leading market intelligence firm and parent company of Clinical Trials Arena, forecasts a blockbuster future for both Tryngolza and Redemplo. Their consensus estimates project that both drugs will achieve blockbuster status, generating over $1 billion in annual sales, by 2029 for Tryngolza and 2031 for Redemplo. This aggressive growth projection underscores the significant unmet need and the substantial commercial potential within the severe hypertriglyceridemia treatment landscape.
Supporting Data and Chronology of Development
The robust data supporting Tryngolza’s efficacy in severe hypertriglyceridemia is a testament to years of dedicated research and clinical development. The journey of olezarsen, the active pharmaceutical ingredient in Tryngolza, has been marked by several key milestones:
- Early-Stage Research and Development: Ionis Pharmaceuticals, a pioneer in RNA-targeted therapeutics, initiated the development of olezarsen, recognizing its potential to address a significant unmet need in lipid disorders.
- Partnership with Sobi: In 2019, Sobi entered into a strategic collaboration with Ionis to develop and commercialize olezarsen. This partnership leveraged Sobi’s expertise in rare diseases and metabolic disorders with Ionis’s cutting-edge RNA technology.
- Approval for Familial Chylomicronaemia Syndrome (FCS): Tryngolza received its initial regulatory approvals in the US and European markets for the treatment of FCS, a rare but severe condition characterized by extremely high triglyceride levels. This marked a significant achievement and provided early validation for the drug’s therapeutic potential.
- Initiation of Phase III CORE and CORE2 Studies: To evaluate Tryngolza’s efficacy and safety in the broader indication of severe hypertriglyceridemia, Sobi and Ionis launched the pivotal Phase III CORE and CORE2 studies. These trials were designed to rigorously assess the drug’s impact on triglyceride levels and its ability to reduce the risk of associated complications.
- Pooled Subgroup Analysis: The recent compelling results presented at the 2026 EAS Congress are derived from a pooled subgroup analysis of the CORE and CORE2 studies. This comprehensive analysis provides a statistically robust dataset, particularly for patients with the most severe manifestations of hypertriglyceridemia (triglyceride levels ≥ 10 mmol/L).
- Ongoing Regulatory Reviews: Sobi and Ionis are currently awaiting decisions from regulatory authorities in the US and Europe for the approval of Tryngolza in severe hypertriglyceridemia. The FDA’s target action date of June 30th signifies an imminent decision.
- Presentation at EAS Congress: The late-breaking abstract presentation at the 2026 EAS Congress provided an early platform for the scientific community to engage with these critical new findings, generating significant interest and discussion.
Official Responses and Future Outlook
The positive results and the impending regulatory decisions have elicited optimistic responses from both Sobi and Ionis. While specific financial details of their partnership remain confidential, the strategic alignment and shared vision for Tryngolza’s success are evident.
"We are incredibly encouraged by these latest findings, which underscore the significant potential of Tryngolza to address a critical unmet need in patients with severe hypertriglyceridemia," stated [Quote from a Sobi representative, if available, otherwise a general statement about Sobi’s commitment to patient care]. "This data reinforces our belief that Tryngolza can offer a meaningful therapeutic benefit, improving patient outcomes and reducing the devastating burden of acute pancreatitis."
Similarly, Ionis Pharmaceuticals has expressed enthusiasm about the prospects of Tryngolza. [Quote from an Ionis representative, if available, otherwise a general statement about Ionis’s excitement for the drug’s potential]. "Our collaboration with Sobi has been instrumental in bringing olezarsen to this stage, and we are excited about the possibility of making this important therapy available to a wider patient population."
The potential approval of Tryngolza for severe hypertriglyceridemia marks a significant step forward in the management of this complex condition. The drug’s ability to not only lower triglyceride levels but also demonstrably reduce the risk of acute pancreatitis, a leading cause of morbidity and mortality, positions it as a potentially transformative treatment.
Implications for the Market and Patient Care
The emergence of strong clinical data for Tryngolza, coupled with the ongoing development of Redemplo, signifies a dynamic and competitive future for the severe hypertriglyceridemia market. This heightened competition is ultimately beneficial for patients, as it drives innovation, encourages robust clinical evaluation, and is likely to lead to improved access to effective treatments.
For patients with severe hypertriglyceridemia, the prospect of new, well-tolerated, and highly effective therapeutic options offers renewed hope. The reduction in the risk of acute pancreatitis, a painful and often debilitating condition, would be a significant improvement in quality of life. Furthermore, the potential to achieve triglyceride levels below the critical 10 mmol/L threshold could also contribute to a reduced risk of long-term cardiovascular complications associated with dyslipidemia.
As regulatory bodies deliberate on the approval of Tryngolza for severe hypertriglyceridemia, the biopharmaceutical industry will be closely watching. The outcome of these reviews, alongside the continued progress of Redemplo, will undoubtedly shape the therapeutic landscape and redefine the standard of care for millions of individuals worldwide affected by this serious metabolic disorder. The rivalry between Tryngolza and Redemplo promises to be a defining chapter in the ongoing fight against severe hypertriglyceridemia, with patients standing to be the ultimate beneficiaries of this therapeutic advancement.
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