– 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.”