Icosabutate latest phase 2b interim data show significant decreases in NASH and fibrosis biomarkers independent of fibrosis stage and disease severity

Icosabutate latest phase 2b interim data show significant decreases in NASH and fibrosis biomarkers independent of fibrosis stage and disease severity Results presented at the AASLD Liver Meeting Digital Experience™ 2021 Significant decreases in key markers of inflammation and fibrogenesis were comparable or of greater magnitude in patients with stage 2/3 fibrosis vs the overall population after 16 weeks in the ICONA trial Greatest reductions in ALT, PRO-C3 and hsCRP seen in patients with highest baseline levels of these markers of disease severity Enrollment completed for ICONA trial in patients with biopsy-confirmed nonalcoholic steatohepatitis, with top-line 52-week histology results expected in Q1-2023 Naarden, The Netherlands, 16 November 2021 – NorthSea Therapeutics B.V., (‘NST’) a biotech company developing novel and innovative strategies for the treatment of NASH and other metabolic diseases, today announces the presentation of new interim data from the Phase 2b ICONA trial during The Liver Meeting Digital Experience™ 2021 (TLMdX) of the American Association for the Study of Liver Diseases (AASLD), which was held online from November 12-15. These latest data are a post-hoc analysis of the prespecified interim analysis of the Phase 2b ICONA trial in biopsy confirmed NASH patients investigating the treatment response in patients with more severe disease at baseline. The ICONA study (ICOsabutate in NASH) is an ongoing 52-week, multicenter, placebo-controlled, phase 2b study which enrolled 280 subjects with biopsy confirmed NASH with stage 1-3 fibrosis, NAS ≥ 4 (1 point in each component) and ≥10% liver fat content by MRI-PDFF. A prespecified interim analysis was performed evaluating multiple non-invasive biomarkers relevant for NASH and fibrosis after 90 participants had been treated through to Week 16. These initial results, presented at the EASL International Liver Congress in early 2021 by Dr. Stephen Harrison, showed a robust treatment effect of icosabutate therapy alongside a favourable safety and tolerability profile. The study is being conducted at 50 sites across the United States and is now fully enrolled as of 15 November. The top-line 52 weeks results are expected in the first quarter of 2023. The current poster presentation entitled “Icosabutate, a Novel Oral Free Fatty Acid 4 (FFAR4) Agonist, Significantly Decreases Biomarkers of NASH and Fibrosis Independent of Disease Severity” will be presented by Dr. Naim Alkhouri, VP of Academic Affairs and Director of the Fatty Liver Program at Arizona Liver Health. “These data give further important insights into the rapid and potent biologic activity of icosabutate across multiple pathways relevant to NASH and fibrosis, several of which have been shown to be predictive of histologic response,” stated Dr. Alkhouri. This post-hoc analysis shows patients with stages 2/3 fibrosis have rapid and sustained significant decreases in all biomarkers at 600 mg and the majority at 300 mg and were comparable or greater than the overall population of stages 1/2/3 fibrosis. Importantly, patients with elevated markers of inflammation and fibrosis at baseline (ALT >60 U/L, PRO-C3 >15.5 ng/ml and hsCRP >3.0 mg/L) had a significantly greater treatment effect on these parameters compared to all subjects. Professor Stephen Harrison, acting Chief Medical Officer at Northsea Therapeutics said, “These data demonstrate the potential for icosabutate to have a strong treatment effect across a broad range of patients. Based on preclinical and clinical data generated to date, along with the favorable safety profile, icosabutate has the potential to be the backbone for either mono- or combination therapy in NASH.” Rob de Ree, Chief Executive Officer at Northsea added, “Northsea is committed to developing novel therapies for patients with life-threatening liver diseases. We are truly grateful to all of the patients and family members who have participated in this important study as well as the investigators and study teams who collaborated with us. With the ICONA trial now fully enrolled, we look forward to seeing these results translating into improvements in liver histology after 52 weeks of treatment and sharing the final results of the ICONA trial in the first quarter of 2023.” Clinical Poster Presentation Title: Icosabutate, a novel oral free fatty acid 4 (FFAR4) agonist, significantly decreases biomarkers of NASH and fibrosis independent of disease severity (Abstract #1915) Authors: Naim Alkhouri, Ann C. Moore, Anita Kohli, Rashmee Patil, Madhavi Rudraraju, Stephen Rossi, David Fraser, Carine Beysen, Stephen A. Harrison and the ICONA Study Investigators Date: November 12-15, 2021 Session: NAFLD and NASH: Therapeutics – Pharmacologic and Other Presentation Type: Poster Presentation A full list of presentations can be found on The Liver Meeting Digital Experience™ 2021 website. The presentations will also be made available on the Northsea Therapeutics website (www.northseatherapeutics.com/science) after the data has been presented at the meeting.

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