NorthSea Therapeutics has kicked off its Phase IIa trial in intestinal failure-associated liver disease (IFALD) after the first patient was dosed with the biotech’s candidate Orziloben (NST-6179).
IFALD is characterised by the development of hepatic inflammation, cholestasis, and steatosis. NorthSea’s randomised, double-blind, placebo-controlled study (NCT05919680) aims to evaluate how well the drug works in adults with the disease that can eventually cause liver failure if untreated.
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The US trial aims to enrol 36 participants with IFALD receiving parenteral nutrition – a type of food administration intravenously that bypasses the digestive system. IFALD is often associated with prolonged administration of parenteral nutrition.
There are currently no US Food and Drug Administration (FDA)-approved therapies to treat IFALD.
The Dutch biotech expects a data readout from its trial in the second half of 2025. The trial’s endpoints include safety assessments, pharmacodynamic effects, and pharmacokinetics.
Orziloben is a synthetic, medium-chain fatty acid analogue (MCFA). It is absorbed via passive diffusion as opposed to receptor-mediated transport. The biotech says that preclinical studies demonstrated the candidates’ ability to prevent multiple pathogenic components of IFALD.
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By GlobalDataNorthSea’s CEO Rob de Ree said: “There is a critical need for effective therapies in IFALD as, to date, there are no drug therapies approved to treat this orphan indication. We believe Orziloben has the potential to make a substantial impact in addressing this unmet medical need.”
Also in the IFALD clinical landscape is Protara Therapeutics’ IV Choline Chloride.
NorthSea’s lead compound is icosabutate, which is licensed from BASF Norge – a company formerly known as Pronova BioPharma Norge. Icosabutate demonstrated a good safety profile in two prior Phase II clinical studies for the treatment of hypertriglyceridemia and mixed dyslipidemia. It also demonstrated positive results in a Phase IIb trial for the treatment of nonalcoholic steatohepatitis.
