AMSTERDAM--(BUSINESS WIRE)--NorthSea Therapeutics B.V., (‘NST’) a Dutch biotech company developing novel and innovative therapies for NASH (Non-alcoholic Steatohepatitis) and other metabolic, inflammatory, and fibrotic diseases based on its SEFA (Structurally Engineered Fatty Acid) technology, today announced a positive interim readout of its ICONA Phase 2b study.
The ICONA study (ICOsabutate in NASH) aims to randomise 264 patients to one of three different 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.
The interim analysis of secondary endpoints from the first 90 patients treated for 16 weeks has been completed and shows good efficacy and positive safety.
The pre-specified hierarchical analysis showed that in the 600 mg group:
- a highly significant (p < 0.0001) reduction in ALT of -25 U/L (-36, -15)*, indicative of reduced liver cell injury
- a highly significant (p < 0.0001) reduction in GGT of -29 U/L (-41, -16)*, indicative of improvement in oxidative stress
- a significant (p < 0.02) reduction in plasma triglycerides (-35% from baseline)
- significant reductions in all fibrosis biomarkers, including Pro-C3
*Treatment difference (95% CI)
The ALT reductions achieved are promising in the context of published data showing that a decrease > 17 U/L is associated with a histological response in NASH patients (1).
(1) Loomba R, et al. Factors Associated with Histologic Response in Adult Patients with Nonalcoholic Steatohepatitis. Gastroenterology 2019;156:88-95 e85
Professor Stephen Harrison, Principal Investigator of the ICONA study, commented: “NASH with fibrosis represents a huge area of unmet need. The positive interim, non-invasive testing data presented, along with the improved metabolic profile, suggest that icosabutate is having a positive impact on both general metabolic health as well as liver health in a short period of time. This is really encouraging for the continuation of the study as we move towards repeat liver biopsy at the end of one year.”
Rob de Ree, NST’s CEO, said: “We are very pleased with the interim data of our ICONA study, showing highly statistically significant reductions in all major biomarkers that are believed to impact NASH resolution and fibrosis. These readings, combined with more than a 50% reduction in hsCRP and GGT, is an early demonstration of icosabutate’s potential as a treatment for NASH patients addressing hepatic inflammation, fibrosis and oxidative stress.”
Professor John Kastelein, member of the Scientific Advisory Board commented: “It is exciting to see that icosabutate improved ALT, AST, gammaGT and bilirubin, which are all changes that point to significant liver-cell repair. In addition, icosabutate lowered triglyceride levels, improved insulin resistance and lowered hsCRP by an impressive 50%, biomarker changes that improve the patient’s cardiovascular risk profile. This profile is exactly what a NASH patient needs: liver repair, lower risk of a heart attack or stroke, reduced hepatic inflammation with a clean safety record. I look forward to the final results from this trial.”
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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 inflammatory, metabolic, and liver diseases. NST licensed the rights to its lead compound icosabutate and a library of discovery- and pre-clinical-stage SEFAs from Pronova BioPharma Norge AS, which developed Omacor®, a blockbuster cardiovascular drug. Icosabutate was been found to be safe and effective in two prior Phase 2 clinical studies for the treatment of hypertriglyceridemia and is currently in clinical development for non-alcoholic steatohepatitis (NASH). A Phase 2b study was initiated in July 2019 (ICONA) to study the efficacy of icosabutate in NASH. NST is headquartered in the Netherlands with a presence in the UK and Norway and is supported by several investors including Forbion, Novo Seeds, BGV, NSV venBio Partners, and Sofinnova Investments. Find out more about us online at www.northseatherapeutics.com