NorthSea Therapeutics Announces Late Breaking Oral Presentation of Phase 2 Topline Data of Orziloben in Intestinal Failure-Associated Liver Disease at AASLD The Liver Meeting® 2026
AMSTERDAM, Nov. 02, 2026 (GLOBE NEWSWIRE) -- NorthSea Therapeutics B.V. (“NorthSea” or the “Company”) is a private,
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AMSTERDAM, Nov. 02, 2026 (GLOBE NEWSWIRE) — NorthSea Therapeutics B.V. (“NorthSea” or the “Company”) is a private, late-stage clinical biotechnology company leveraging its proprietary SEFA™ platform to develop novel drugs addressing the multiple pathways implicated in rare heterogenous liver diseases. Today, NorthSea announced that an abstract on topline data from its Phase 2 study of orziloben (NST-6179) in adults with intestinal failure-associated liver disease (IFALD) has been selected for a late-breaking oral presentation. The presentation will be given at the American Association for the Study of Liver Disease’s The Liver Meeting® 2026, which is taking place November 5-9, 2026, in Denver, Colorado.
Oral Presentation Details
Title: Phase 2, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Orziloben (NST-6179) in Adults with Intestinal Failure-Associated Liver Disease (IFALD)
Session Title: Late Breaking Abstract Parallel Session 2
Publication Number: 5012
Presenter: Manpreet Mundi, M.D., The Mayo Clinic, Rochester, MN
Session Date and Time: November 8, 2026, 5:00-6:30 p.m. MST
Presentation Time: 6:15-6:30 p.m. MST
About Orziloben
Orziloben is a novel, highly bioavailable and potent, oral drug candidate that is administered once daily for the treatment of intestinal failure associated liver disease (IFALD). Orziloben is a fully synthetic small molecule that is passively absorbed from the gut and directly targets the liver via the portal vein. Orziloben’s differentiated multi-modal mechanism addresses three key biological drivers of IFALD: cholestasis (PPAR-α), inflammation (GPR84), and fibrosis (PPAR-γ).
About Intestinal Failure Associated Liver Disease (IFALD)
Intestinal failure-associated liver disease (IFALD) represents one of the most serious and life-threatening conditions in patients with intestinal failure (IF) receiving parenteral nutrition (PN). IFALD is a heterogenous liver disease, characterized by progressive hepatic dysfunction, manifesting as persistent cholestasis, hepatic inflammation, fibrosis, and ultimately biliary cirrhosis.1 There are an estimated 53,0002 patients in the United States with chronic intestinal failure. Of these, approximately 15-40% of adults and approximately 40-60% of children develop IFALD.3
About our Phase 2
The Phase 2 trial was a randomized, double-blind, placebo-controlled study, evaluating safety, tolerability, pharmacokinetics, and pharmacodynamic effect of orziloben 800 mg oral administration once daily in adult patients with IFALD versus placebo for four weeks of treatment, and orziloben 1200 mg oral administration once daily for 12 weeks. The trial has evaluated reductions from baseline in alkaline phosphatase (ALP), gamma-glutamyl transferase (GGT), bilirubin, aspartate transaminase (AST), and alanine transaminase (ALT).
About NorthSea Therapeutics
NorthSea Therapeutics B.V. is a private, late-stage clinical biotechnology company that leverages its SEFA™ platform to develop novel drugs that target cholestatic, inflammatory, and fibrotic pathways to treat rare heterogenous liver diseases that require a multi-modal mechanism of action. Its proprietary SEFAs are designed to target each of these key disease pathways simultaneously in a single, oral dose, offering potential first-in-class treatments. NorthSea’s lead program is orziloben, a Phase 2 program for the treatment of intestinal failure associated liver disease (IFALD). NorthSea’s investors include Forbion, Ysios Capital, venBio, Novo Seeds, Sofinnova, BGV, and New Science Ventures. Headquartered in the Netherlands, NorthSea also has a presence in the U.S. and Norway. To learn more, visit https://northseatherapeutics.com/en/.
1Pironi et al. 2023; Cuerda et al. 2021; Di Dato et al. 2022
2 Komodo Claim Data Analysis; April 2026
3Zafirovska, M.; Zafirovski, A.; Rotovnik Kozjek, N. Current Insights Regarding Intestinal Failure-Associated Liver Disease (IFALD): A Narrative Review. Nutrients 2023, 15, 3169. https://doi.org/10.3390/nu15143169
Media and Investor Contact
Argot Partners
Julie Fallon
northsea@argotpartners.com
(508) 816-5683
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