#Sweden #Stockholm #Sobi #Olezarsen #sHTG

Exciting Advances in Hypertriglyceridemia Treatment

At the recent American Heart Association (AHA) Scientific Sessions, groundbreaking results from the Phase 3 studies of olezarsen were unveiled. Conducted by the TIMI Study Group, these pivotal trials focused on patients suffering from severe hypertriglyceridemia (sHTG). The findings indicate not only a significant reduction in fasting triglyceride levels but also a remarkable decrease in acute pancreatitis incidents, which is a life-threatening condition often linked to extreme triglyceride levels.

The CORE and CORE2 studies highlighted a staggering 72% placebo-adjusted mean reduction in fasting triglycerides at six months in patients treated with olezarsen. Importantly, this reduction was sustained over a 12-month period. In a population where hypertriglyceridemia poses numerous challenges, these results mark a significant advancement in treatment options, with 86% of participants achieving triglyceride levels below the critical threshold of 500 mg/dL.

Dr. Nicholas Marston from Brigham and Women’s Hospital emphasized the critical nature of these findings, stating, “These studies are the first to demonstrate a substantial reduction in acute pancreatitis events in patients with sHTG.” Acute pancreatitis can lead to debilitating pain and lengthy hospital stays, making its prevention crucial for patient safety. This treatment could dramatically improve the quality of life for many affected individuals, especially those for whom traditional therapies have proven insufficient.

The CORE and CORE2 studies enrolled nearly 1,100 participants, making it the largest pivotal program for sHTG to date. These randomized, double-blind, placebo-controlled trials aimed to assess the safety and efficacy of olezarsen by comparing its effects against a placebo over a duration of 12 months. By requiring participants to be on standard lipid-lowering therapy, the studies aimed to capture the real-world effectiveness of olezarsen in managing triglyceride levels.

One notable subgroup within the study consisted of patients with triglyceride levels exceedingly high, often exceeding 880 mg/dL, which relates closely to multifactorial chylomicronemia syndrome (MCS). The results concerning triglyceride reduction and acute pancreatitis prevention were consistent across both the general and the higher-risk populations. This alignment hints at the broad applicability of olezarsen, providing hope to those dealing with severe triglyceride issues.

Additionally, olezarsen stood out not only for its efficacy but also its safety profile. Adverse events were balanced across treatment arms, and serious adverse events occurred less frequently in the olezarsen groups compared to those on placebo. The most commonly reported side effects included injection site reactions, generally mild in nature, thus reinforcing the tolerability of this new therapy.

Sobi, the biopharmaceutical company behind olezarsen, plans to further develop this promising treatment. Lydia Abad-Franch, Sobi's CMO, expressed optimism regarding the future plans for olezarsen, particularly regarding its European submission for approval aimed for the coming year. “These results confirm our belief in the potential of olezarsen to significantly elevate the quality of life for patients enduring severe hypertriglyceridemia for years,” she stated.

As the medical community continues to recognize the serious implications of untreated high triglyceride levels, olezarsen emerges as a glimmer of hope for improved management of sHTG. With ongoing studies, including an open-label extension aimed at monitoring patients beyond the initial trials, the future of olezarsen looks promising not only for those directly impacted by hypertriglyceridemia but also for the broader healthcare landscape.

In conclusion, the pivotal studies of olezarsen represent a vital step forward in the treatment of severe hypertriglyceridemia. With evidence showing significant triglyceride reduction and a marked decrease in life-threatening acute pancreatitis episodes, olezarsen holds the potential to transform patient outcomes in this under-addressed area of cardiovascular health.