NorthSea Therapeutics secures €25m funding for NASH drug development

NorthSea Therapeutics (NST), a newly established Dutch biotech company, announced the completion of a €25 million Series A funding 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 led by Forbion and BGV includes Novo Seeds, the early-stage investment arm of Novo Holdings 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, a leader in this space.

NASH is caused by inflammation and damage to the liver, which is the result of deposition of too much fat in the liver cells. An estimated 15–30 m 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 €25 m 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 NST 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 a good access to clinical trial sites and backing by a strong syndicate of investors,” said Rob de Ree, CEO at NST.

“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 Professor Scott Friedman (Mount Sinai, NYC), Professor 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: “NST 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 NST can build a straight road to pivotal registration studies. I am looking forward to being part of this exciting endeavour.”

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 (a BGV Operating Partner), Søren Møller (Novo Seeds) and Somu Subramaniam (NSV).

In addition, Oskar Slotboom of 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 Professor John Kastelein, as an independent board member.