• NST becomes a multi-asset clinical development company, beyond NASH
• Pre-clinical studies have demonstrated broad and marked beneficial effects of SEFA-1024 on non-HDL cholesterol, triglycerides, and HDL cholesterol and glycemic control
• A third clinical development program, SEFA 6179, for treating Intestinal Failure- Associated Liver Disease (IFALD) will start Phase 1 studies in the first half of 2021
Naarden, The Netherlands, 19 November 2020 – 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 platform, today announces the dosing of the first patient with SEFA-1024 in a Phase 1 study. ‘SEFA’ stands for Structurally Engineered Fatty Acid, i.e. chemically engineered fatty acids, to generate compounds with differentiated physiochemical properties.
This Phase 1 trial will evaluate the safety, tolerability, and pharmacokinetics of SEFA-1024 in 96 otherwise healthy volunteers with elevated plasma triglyceride levels. Hypertriglyceridemia may cause acute pancreatitis and is often associated with other conditions that increase the risk of heart disease and stroke, including type 2 diabetes, obesity, and metabolic syndrome.
SEFA-1024 is a novel, orally-administered, highly potent, chemically modified fatty acid derived from naturally occurring fatty acid EPA. SEFA-1024 was designed to enhance its pharmacological effects on metabolic markers in the intestine and liver
In pre-clinical dyslipidemia models, SEFA-1024 exhibited broad and marked beneficial effects, significantly reducing both non-HDL cholesterol and triglycerides in conjunction with an increase in HDL cholesterol. The cholesterol-lowering activity of SEFA-1024 was additive to the lowering obtained with statin treatment, suggesting that SEFA-1024 could be used in combination with these important standard-of-care cardiovascular therapies. Further, it was shown that dosing with SEFA-1024 leads to marked improvements in glycemic control, indicating that SEFA-1024 has the potential to improve overall glycemic control in patients with diabetes.
Professor John Kastelein, NST scientific advisory board and supervisory board member commented: “SEFA-1024 has shown, in a range of pre-clinical models, a broad effect on major metabolic markers and the availability of the oral, once-daily therapy could optimize the management of multiple dyslipidemia diseases in patients with high triglycerides or mixed dyslipidemia”.
Rob de Ree, NST’s CEO said: “The commencement of the SEFA-1024 trial is a significant landmark in our move to become a multi-asset company, expanding beyond the success so far of our existing program in liver disease, and delivering on our promise to produce multiple clinical candidates with the SEFA technology. Our move to focus on dyslipidemia enables us to target new disease areas with products where the potential to help patients reach their therapeutic targets with a convenient oral therapy is substantial”.
SEFA-1024 is one of NST’s three SEFA programs. NST’s lead program, icosabutate, is currently in a phase 2b ‘ICONA’ study for the treatment of NASH. The Company’s third SEFA, 6179, is expected to enter the clinic in the first half of 2021, targeting IFALD, for which no treatment is currently available.
For further information:
NorthSea Therapeutics B.V.
Rob de Ree (CEO)
Tel: +31 356993000
Dr Christelle Kerouedan / Melanie Toyne-Sewell
E-mail: NorthSea@instinctif.com Tel: +44 20 7457 2020
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