• Lead drug icosabutate, in-licensed from Pronova BioPharma AS
  • Phase IIb-ready at the end of 2018
  • Investment syndicate led by Forbion and BGV, and includes Novo Seeds and New Science Ventures

Naarden, The Netherlands, 12 December 2017 – BGV, an early stage European venture capital company, announced that NorthSea Therapeutics B.V., (‘NST’) a newly established Dutch biotech company, has completed a €25m Series A fundraising for the development of icosabutate, a structurally engineered fatty acid (‘SEFA’) as a novel, oral approach for the treatment of non-alcoholic steatohepatitis (‘NASH’).

The investment syndicate was led by Forbion and BGV, and includes Novo Seeds, the early-stage investment arm of Novo Holdings A/S and New Science Ventures.

Icosabutate has been found safe and effective in two prior phase II clinical studies for treatment of hypertriglyceridemia. This compound and a library of discovery- and pre-clinical-stage SEFAs are in-licensed from Pronova BioPharma Norge AS, a leader in this space.

NASH is the result of the deposition of too much fat in the liver cells. An estimated 15 to 30 million patients in the six major markets will develop NASH in the coming years. This trend is, in part, secondary to the growing incidence of obesity, type 2 diabetes, and metabolic syndrome. Further disease progression in NASH patients leads to fibrosis and cirrhosis with high risk for liver failure, hepatocellular cancer and need for liver transplantation.

The €25m financing round is to conduct a phase IIb clinical study in NASH with icosabutate and to develop it to phase III readiness, including clinical and non-clinical toxicology studies and CMC development.

NST is headed up by an experienced team of executives from the dyslipidemia and liver disease space. Rob de Ree and Patrick Round, who were instrumental in the success of Dezima Pharma, are CEO and CMO respectively. Hilde Steineger (COO), David Fraser (CSO), and Tore Skjaeret, (VP Chemistry and CMC), all bring deep experience in the development of SEFAs, including icosabutate.

“At its inception NorthSea Therapeutics has all the ingredients for success in the competitive NASH space. It has a promising and clinically tested compound, a team with experienced drug developers, world-leading experts in the field with good access to clinical trial sites and backing by a strong syndicate of investors” said CEO Rob de Ree. “We believe icosabutate has the potential to impact the lives of millions of NASH patients globally, for whom there are currently little treatment options available.”

The company is also supported by a world-renowned team of clinical and scientific advisors, including Prof. Scott Friedman (Mount Sinai, NYC), Prof. Detlef Schuppan (University of Mainz), and Dr. John Kastelein, Professor of Medicine at the Department of Vascular Medicine at the Academic Medical Center (AMC) in Amsterdam

Dr. John Kastelein added: “NorthSea Therapeutics and its lead compound, icosabutate, are in an ideal position to move rapidly into more advanced stage clinical trials to establish the role of this potent but very safe, structurally engineered omega-3 fatty acid in the treatment of NASH. A very promising molecule,both in pre-clinical as well as in clinical studies and a world-class advisory board are the foundations upon which NorthSea Therapeutics can build a straight road to pivotal registration studies. I am looking forward to being part of this exciting endeavour.”

Oskar Slotboom, Partner at BGV said: “Our investment in NorthSea Therapeutics fits very well with our strategy to focus on innovations that are differentiating in areas of unmet medical need.  NASH is a disease where no effective treatment is currently available. The lead compound icosabutate is clearly differentiated as it targets multiple pathways in NASH pathogenesis and is expected to enter into pivotal phase IIb trials soon.”

From the investor synicate, the following representatives will join the board of NST: Sander Slootweg (Chair, on behalf of Forbion), Marco Boorsma (also Forbion), Rob de Ree (BGV Operating Partner), Søren Møller (Novo Seeds) and Somu Subramaniam (NSV). In addition, Oskar Slotboom partner at BGV will be an observer to the board. NST’s COO Hilde Steineger will also join the board on behalf of the founders, as will Prof. Dr. John Kastelein, as an independent board member.