AMSTERDAM – (BUSINESS WIRE) – January 8, 2021–
NorthSea Therapeutics BV (‘NST’), a Dutch biotech company developing novel and innovative therapies for NASH (Alcohol-Free Steatohepatitis) and other metabolic, inflammatory and fibrotic diseases based on its SEFA (Structurally Engineered Fatty Acid) technology , announced today a positive interim report from the ICONA phase 2b study.
The ICONA study (ICO-Sabutat in NA SH) aims to randomize 264 patients into one of three different treatment groups: placebo, icosabutate 300 mg once daily, or icosabutate 600 mg once daily for 52 weeks of treatment. The primary endpoint of the study is resolution of NASH without worsening fibrosis based on changes in liver biopsy parameters from baseline at 52 weeks.
The interim analysis of the secondary endpoints of the first 90 patients treated for 16 weeks is complete and shows good efficacy and positive safety.
The given hierarchical analysis showed that in the 600 mg group:
- a highly significant (p <0.0001) decrease in ALT of -25 U / L (-36, -15) *, indicating decreased liver cell injury
- a highly significant (p <0.0001) decrease in GGT of -29 U / L (-41, -16) *, which indicates an improvement in oxidative stress
- a significant (p <0.02) reduction in plasma triglycerides (-35% compared to baseline)
- significant reduction in all fibrosis biomarkers, including Pro-C3
* Treatment difference (95% CI)
The ALT reductions achieved are encouraging 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 related to the histological response in adult patients with non-alcoholic steatohepatitis. Gastroenterology 2019; 156: 88- 95 e85
Professor Stephen Harrison, Principal Investigator of the ICONA study, commented, “NASH with fibrosis is a huge area where the need cannot be met. The positive preliminary, non-invasive test data as well as the improved metabolic profile suggest that icosabutate has a positive effect on both general metabolic health and liver health in a short period of time. This is very encouraging for the study to continue as we turn to a repeat liver biopsy after a year. “
Rob de Ree, CEO of NST, said, “We are very pleased with the interim data from our ICONA study which shows statistically highly significant reductions in all major biomarkers believed to affect NASH dissolution and fibrosis. These readings, combined with more than 50% reductions in hsCRP and GGT, provide early evidence of icosabutate’s potential in the treatment of NASH patients battling hepatitis, fibrosis and oxidative stress. “
Scientific Advisory Board member Professor John Kastelein commented, “It is exciting to see icosabutate ameliorating ALT, AST, GammaGT and bilirubin, all of which are changes that indicate significant liver cell repair. Additionally, 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 heart attack or stroke, reduced liver inflammation with a clean safety record. I look forward to the final results of this study. “
About NorthSea Therapeutics
NorthSea Therapeutics BV (NST) is a Dutch biotech company focused on the development of structural 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 SEFAs from Pronova BioPharma Norge AS developing Omacor ®, a blockbuster cardiovascular drug. Icosabutate has been shown to be safe and effective in two previous Phase 2 clinical trials for the treatment of hypertriglyceridemia and is currently in clinical development for non-alcoholic steatohepatitis (NASH). A phase 2b study (ICONA) was started in July 2019 to investigate the effectiveness of icosabutate in NASH. NST is headquartered in the Netherlands and has a presence in the UK and Norway. The company is supported by several investors, including Forbion, Novo Seeds, BGV, NSV venBio Partners and Sofinnova Investments. Learn more about us online at www.northseatherapeutics.com
CONTACT: NorthSea Therapeutics BV
Tel: +31 356993000 Media Contact: Instinctif Partners
Melanie Toyne-Sewell / Phil Marriage
KEYWORD: THE NETHERLANDS EUROPE
KEYWORD IN INDUSTRY: BIOTECHNOLOGY PHARMACEUTICAL HEALTH CLINICAL TRIALS
SOURCE: NorthSea Therapeutics BV
Copyright Business Wire 2021.
PUB: 08/01/2021 03:00 am / DISC: 08/01/2021 03:00 am
Copyright Business Wire 2021.