- NorthSea Therapeutics’ lead candidate, Icosabutate, is an oral, once-daily, Structurally Engineered Fatty Acid (SEFA) developed to treat non-alcoholic steatohepatitis (NASH). Icosabutate has proven to be efficacious in multiple pre-clinical NASH models and demonstrated normalization of liver enzymes in hyperlipidemic subjects with elevated baseline levels in Phase 2 studies. We are currently conducting a placebo-controlled Phase 2b trial of Icosabutate in 264 patients with biopsy-proven NASH with the primary endpoint being the resolution of NASH without the worsening of fibrosis.
- In addition to developing Icosabutate for NASH, we are actively developing two additional SEFA pipeline products; SEFA-1024 and SEFA-6179. In preclinical models, SEFA-1024 has broad and potent beneficial effects on non-HDL cholesterol, triglycerides, and HDL cholesterol. The cholesterol-lowering activity of SEFA-1024 was additive to that obtained with statin treatment, suggesting that SEFA-1024 could be used in combination with these important standard-of-care cardiovascular therapies. We also showed that dosing with SEFA-1024 leads to potent improvements in glycemic control, providing an opportunity to potentially treat hyperlipidemia patients with diabetes. We are completing Phase 1-enabling studies with SEFA-1024 and anticipate filing a CTA in the second half of 2020.
- SEFA-6179 is being developed as an oral therapy for parenteral nutrition-associated liver disease (PNALD). PNALD is an orphan liver disease caused by long term use of parenteral nutrition. There are no approved treatments for the disease in adults. In several pre-clinical models of PN-induced liver injury, hepatic steatosis is completely prevented by the administration of SEFA-6179. Piglet PK studies demonstrated an acceptable uptake of SEFA-6179 via the oral route and we have commenced the formal GLP toxicology program to enable an IND filing in the first half of 2021.