Ionis and Sobi’s Tryngolza Delivers 66% Triglyceride Drop; FDA Decision June 30
IONS•Ionis and Sobi’s pooled Phase III CORE and CORE2 analysis shows 80mg Tryngolza reduced triglycerides ≥10 mmol/L by 66% placebo-adjusted at six months, with 50mg achieving a 59% drop and 85% of patients reaching sub-10 mmol/L levels. The FDA decision due June 30 will determine its launch in severe hypertriglyceridemia.
1. Pooled Phase III Efficacy Results
The pooled subgroup analysis of Phase III CORE (NCT05079919) and CORE2 (NCT05552326) studies evaluated Tryngolza's impact in patients with baseline triglycerides ≥10 mmol/L. At six months, patients receiving 80mg every four weeks achieved a 66% placebo-adjusted triglyceride reduction, while the 50mg cohort saw a 59% drop, and 85% reached levels below 10 mmol/L, meeting the European Atherosclerosis Society’s urgent treatment cutoff.
2. Regulatory Timeline and Market Expansion
Ionis Pharmaceuticals retains US commercialization rights for Tryngolza, with Sobi handling territories outside the US, excluding Canada and China. Both companies are awaiting the FDA’s target action date of June 30 for a label expansion into severe hypertriglyceridemia, which would broaden use beyond the current familial chylomicronaemia syndrome indication.
3. Competitive Landscape and Commercial Implications
Successful FDA approval could position Tryngolza as a leading hypertriglyceridemia therapy, potentially addressing a patient population at quadruple risk of acute pancreatitis. Arrowhead Pharmaceuticals’ Redemplo (plozasiran) is a key competitor in late-stage trials, highlighting a competitive siRNA market for triglyceride lowering, with material revenue implications upon launch.
