Potential of Icosabutate as a Novel Approach to the Treatment of NASH Highlighted in Late-Breaker At The International Liver Congress™ 2018

• Icosabutate, a structurally engineered fatty acid, displays optimised phamacokinetics for targeting both metabolic and inflammatory pathways in the liver, both with key relevance for NASH

• Pre-clinical data show broad and powerful pharmacodynamic effects on plasma lipids, glucose metabolism, hepatic inflammation and fibrosis

• Clinical phase 2 data study demonstrated normalisation of elevated baseline liver enzymes in dyslipidemic patients treated with icosabutate 600mg once daily for 12 weeks

• The combined data provide a strong impetus for phase 2b NASH trial initiation in late 2018

NAARDEN, The Netherlands I April 12, 2018 I NorthSea Therapeutics B.V., (‘NST’) a newly established Dutch biotech company aiming to develop novel and innovative strategies for the treatment of NASH and other metabolic, inflammatory and fibrotic diseases, announces the publication of a late-breaker abstract and poster to be presented at The EASL International Liver Congress™ 2018 in Paris on 12-14 April.

NorthSea Therapeutics’ lead product, icosabutate is a structurally designed fatty acid that regulates pivotal lipid pathways involved in hepatic inflammation and fibrosis.

Commenting on the late-breaker category, Dr. David A. Fraser, CSO, said: “The late-breaker category is devoted to novel and outstanding scientific discoveries, therefore, we are delighted to be accepted to present our data in this class. The International Liver Congress™ 2018 provides us with the ideal platform to demonstrate the unique therapeutic potential of structurally engineered fatty acids, as exemplified here by icosabutate, for pleiotropic targeting of metabolic and inflammatory liver disorders. With this data, we are on track to take this programme into Phase 2b later this year.”

The presented data indicate that icosabutate has favourable pharmacokinetics, and significant therapeutic benefit in animal models of NASH and overall diet-induced inflammation and fibrosis. In particular, icosabutate is shown to improve glucose tolerance in insulin resistant rodent models.

In a 12-week phase 2 clinical study in dyslipidemic patients, icosabutate markedly decreased elevated liver enzymes at a well-tolerated 600mg once daily oral dose (CTN 4016 13201), whereas enzyme levels were unchanged in patients taking placebo. Decreases in liver enzymes are known to correlate with positive histological responses to therapeutic interventions in clinical trials in NASH, and hence these data strongly support the pre-clinical observations demonstrating the robust hepatoprotective and antifibrotic effect of icosabutate in NASH models.

Professor Detlef Schuppan, Scientific Advisory Board member and world-renowned expert in liver fibrosis and NASH, said, “Icosabutate is an exciting potential drug as it exhibits highly potent effects on hepatic inflammation, in addition to improvements in insulin resistance and antifibrotic potency. We are looking forward to continuing our research on both its antifibrotic and overall mechanisms of action.”

Two previously phase 2 clinical studies on icosabutate have been published already, demonstrating significant triglyceride and cholesterol-lowering effects, significant improvements in glucose metabolism and excellent safety. With this new clinical study, the combined data presented supports the continuing development of icosabutate as an effective and safe therapeutic approach to treating both NASH and its associated comorbidities. Icosabutate is on course to be phase 2b-ready by the end of 2018.

Commenting on the combined preclinical and clinical results, Professor John J. Kastelein, Scientific and Advisory Board member, added: “Next to the robust preclinical data in NASH models, the clinical observations in phase 2 with icosabutate show excellent results. These include a good safety profile, suggest a decrease in liver fat and demonstrate a very attractive reduction of cardiovascular risk through modulation of lipid and glucose metabolism, which other classes of drugs seldom show.”

The poster is available to view on the NorthSea Therapeutics website: www.northseatherapeutics.com/easl-latebreaker

For more information please visit the NorthSea team in the poster area of the conference:

Poster title: A structurally engineered fatty acid, icosabutate, displays optimised absorption, distribution and metabolism properties for targeting hepatic inflammation and normalises elevated liver enzymes in dyslipidemic patients

Authors: Fraser DA, Wang X, Skjaeret T, Kastelein JP, Schuppan D

Date: 09:00 – 17:00 Thursday 12th to Saturday 14th April

Location: Hall 7.2, poster area 2, LBP-026

About NASH

NASH is liver inflammation and damage caused by a build-up of fat in the liver. It is the advanced stage non-alcoholic fatty liver disease (NAFLD), which start with fatty liver and insulin resistance. Although a similar condition can occur in people who abuse alcohol, NASH occurs in those who drink little to no alcohol. It is frequently associated with certain disorders such as diabetes, obesity, and insulin resistance which are major contributors to the highly prevalent metabolic syndrome. An estimated 15 – 30% of most populations suffers from NAFLD, 10 – 15% of whom may advance to NASH representing at least ~15 – 30 million patients in the 6 major markets. Further disease progression in 15-20% of NASH patients leads to advanced liver fibrosis and cirrhosis with a high risk of liver failure, hepatocellular cancer and need for liver transplantation.

About NorthSea Therapeutics

NorthSea Therapeutics B.V.(NST) is a 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, who developed OmacorÒ, a blockbuster cardiovascular drug. Icosabutate has been found safe and effective in two prior phase 2 clinical studies for treatment of hypertriglyceridemia and is currently in clinical development for NASH, aiming to be phase 2b ready by end 2018. NST is a Dutch company, with employees based also in the UK and Norway.

SOURCE: NorthSea Therapeutics

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