5 January 2023
NorthSea Therapeutics provides clinical update reflecting progress across NASH and metabolic disorders programmes
NorthSea Therapeutics now has three phase II clinical stage assets in development based on its SEFA platform
Top line results of Phase 2b ICONA trial with lead programme icosabutate for NASH expected in Q1 2023
Phase 1 trial with SEFA-1024 (being developed for the treatment of severe hypertriglyceridemia) completed in Q4 2022 and is expected to move to Phase 2 in H1 2023
Phase 1 trial with SEFA-6179 (being developed for the treatment of intestinal failure associated liver disease (IFALD) completed in Q4 2022 and is anticipated to progress to Phase 2 in H1 2023
Amsterdam, The Netherlands, 5 January 2023 – NorthSea Therapeutics B.V. (‘NST’, or the ‘Company’), a biotech company developing novel and innovative strategies for the treatment of non-alcoholic steatohepatitis (NASH) and other metabolic diseases, today provides an update on its clinical pipeline of structurally engineered fatty acids (‘SEFAs’), a new class of fatty acids drugs, for the treatment of non-alcoholic steatohepatitis (NASH) and other metabolic disorders.
NST’s lead product, icosabutate, is a once-daily, oral SEFA currently in a Phase 2b clinical trial (ICONA) for the treatment of non-alcoholic steatohepatitis, or NASH. The ICONA study randomized 280 patients to one of three treatment groups: placebo, icosabutate 300 mg once daily, or icosabutate 600 mg once daily, with a treatment period of 52 weeks. The study’s primary endpoint is resolution of NASH without worsening of fibrosis, based on changes in liver biopsy parameters compared to baseline after 52 weeks.
Positive interim results for the ICONA trial were announced in January 2021, showing significant decreases in NASH and fibrosis biomarkers independent of fibrosis stage and disease severity. Icosabutate was also well-tolerated, with no serious safety signals to date, a key attribute for patients with NASH, who require chronic therapy.
Based on the positive interim ICONA data, together with NST’s preclinical and other clinical data, the Company believes icosabutate has the potential to be the preferred backbone therapy for the treatment of NASH, either as a monotherapy or as a combination therapy. Top line results are anticipated in Q1 2023.
SEFA-1024 is an oral, highly lipophilic SEFA for the treatment of severe hypertriglyceridemia that is designed to target the gut-liver axis and to concurrently improve plasma lipids and glycemic control. NST has concluded a Phase 1 clinical trial with single and multiple ascending doses and a drug-to-drug interaction study of SEFA-1024 in healthy volunteers with excellent safety profiles and encouraging early signs of improved lipid profiles, such as plasma triglycerides, LDL cholesterol and apolipoproteins ApoC3 and ApoB. The plan is for SEFA-1024 to start Phase 2 in H1 2023.
NST is also developing SEFA-6179 – a novel, oral, fully synthetic medium chain fatty acid analogue – for the treatment of intestinal failure-associated liver disease, (IFALD), an orphan liver disease affecting individuals on prolonged parenteral nutrition. The unique pharmacologic properties of SEFA-6179 facilitate intestinal uptake, which is critical for ensuring optimal drug absorption in patients with intestinal failure and short bowel syndrome and has demonstrated strong anti inflammatory and anti-cholestatic effect in pre-clinical parenteral nutrition induced liver injury models. A phase 1 single and multiple ascending dose study has been successfully completed. SEFA-6179 will advance to Phase 2 in H1 2023.
Rob de Ree, NST’s CEO, commented: “We are very pleased with the significant progress we have made during 2022 in the clinical development of all three of our SEFA programmes. We welcome 2023 with great anticipation, especially with the ICONA readout in Q12023, renewing our commitment to developing new programs with the potential to have a significant impact on patient care.”
David Fraser, CSO and co-founder, added: “We are excited about the potential of our SEFA platform, a new class of engineered fatty acid drugs, and we are highly encouraged by the results we have achieved so far with our unique therapeutic approach to targeting metabolic, inflammatory and fibrotic diseases. We are delighted that the Company has advanced three SEFAs into clinical development and we are dedicated to further advancing innovative therapies for patients with high unmet medical needs based on our SEFA platform.”
Notes to Editors
About NorthSea Therapeutics
NorthSea Therapeutics B.V.(NST) is a Dutch biotech company focused on developing structurally engineered fatty acids (‘SEFAs’) for the treatment of NASH and other metabolic disorders. NST licensed the rights to its lead compound icosabutate and a library of SEFAs from Pronova BioPharma Norge AS, who developed Lovaza (US brand, branded Omacor in Europe), a blockbuster cardiovascular drug. Icosabutate has been found safe and effective in two prior phase 2 clinical studies for treatment of severe and moderate hypertriglyceridemia and is currently in clinical development for NASH. The icosabutate phase 2b ICONA NASH trial is scheduled to readout in the first half of 2023. Two additional SEFAs are in clinical development; SEFA-1024 has completed a phase 1 study and is being developed for SHTG, whilst SEFA-6179 completed a phase 1 study in Q4-2022 and is being developed for the orphan indication IFALD, (Intestinal Failure Associated Liver Disease). NST is headquartered in the Netherlands with a presence in Norway and the US and is supported by Ysios Capital, Forbion Growth, Forbion Ventures, Novo Seeds, BGV, NSV, venBio Partners and Sofinnova investments.
Find out more about us online at: www.northseatherapeutics.com
NorthSea Therapeutics B.V.
Rob de Ree (CEO)
Tel: +31 356993000
Instinctif Partners (Media)
Melanie Toyne-Sewell / Giulia Lasagni / Adam Loudon
Tel: +44 20 7457 2020