NorthSea Taps Rare Disease Expert for Board as Key Liver Drug Advances

AMSTERDAM – March 31, 2026 – NorthSea Therapeutics has fortified its leadership team with a high-profile appointment, signaling a strategic shift towards late-stage development and potential commercialization for its lead drug candidate, orziloben. The private Dutch biotechnology firm announced the addition of Dr. Pamela Vig, a veteran executive with a formidable track record in bringing rare disease therapies to market, to its Board of Directors.

The move comes as NorthSea prepares to advance orziloben, a potential first-in-class treatment for Intestinal Failure-Associated Liver Disease (IFALD), into the later stages of clinical testing. The company anticipates a pivotal data readout from its ongoing Phase 2 trial in the third quarter of this year, a milestone that could validate its innovative technology platform and offer hope for a condition with no approved pharmacological treatments.

A Strategic Appointment for a New Growth Phase

Dr. Vig’s appointment is being viewed by industry observers as a calculated and significant step for NorthSea. With over 30 years of experience, her career is marked by successful leadership roles in navigating the complex path from clinical research to regulatory approval and commercial launch, particularly in the rare and liver disease sectors.

Most notably, Dr. Vig co-founded Mirum Pharmaceuticals and served as its Chief Scientific Officer. During her tenure, Mirum successfully secured FDA approval for Livmarli, a treatment for rare cholestatic liver diseases in children, including Alagille syndrome and progressive familial intrahepatic cholestasis (PFIC). This direct experience in shepherding a pediatric rare liver disease drug through to market is precisely the expertise NorthSea needs as it enters a similar phase with orziloben.

“We are delighted to welcome Pam to our Board,” said Sander Slootweg, Chair of NorthSea’s Board of Directors. “She brings a valuable combination of drug development expertise, specifically in the rare liver disease space, and commitment to scientific innovation that will support our next phase of growth.”

Before Mirum, Dr. Vig held senior roles at Tobira Therapeutics, which was acquired by Allergan, and Janssen Therapeutics, a Johnson & Johnson company. Her extensive background provides NorthSea with a wealth of knowledge in clinical strategy, regulatory affairs, and the commercial realities of the biopharmaceutical landscape.

“Pam's clinical and regulatory expertise and guidance will be invaluable to us as we continue to advance orziloben and our rare liver disease portfolio,” noted Rob de Ree, Chief Executive Officer of NorthSea.

Targeting a Critical Unmet Need in Pediatric Care

The focus of NorthSea's immediate efforts is orziloben and its potential to treat IFALD, a severe and often life-threatening complication that primarily affects infants and children. These patients suffer from intestinal failure and require long-term parenteral nutrition (PN), where nutrients are delivered intravenously. While life-saving, prolonged PN can be toxic to the liver, leading to a cascade of problems from cholestasis (reduced bile flow) to inflammation, progressive fibrosis, cirrhosis, and ultimately, liver failure requiring transplantation.

With incidence rates historically reported as high as 40-60% in infants on long-term PN, the need for a targeted therapy is immense. Currently, the standard of care is limited to preventative and supportive measures, such as optimizing PN formulas with fish-oil-based lipids and managing infections. There are no approved drugs specifically designed to halt or reverse the underlying liver damage caused by IFALD.

Recognizing this critical gap, regulatory bodies have granted orziloben significant incentives. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have both granted it Orphan Drug Designation. Furthermore, the FDA has provided a Rare Pediatric Disease Designation, which not only underscores the drug's importance for a small, vulnerable population but also makes it eligible for a Priority Review Voucher upon approval. This voucher, which can be sold to other companies for millions, represents a valuable asset that can fund future research.

The Science Behind the Hope: NorthSea's SEFA Platform

At the core of NorthSea’s innovation is its proprietary Structurally Engineered Fatty Acids (SEFAs) platform. Rather than using naturally occurring fatty acids, the company’s scientists design and synthesize novel fatty acid molecules engineered to have specific therapeutic effects. Orziloben is the lead candidate to emerge from this platform.

The company’s approach is designed to create drugs with a multi-modal mechanism of action, simultaneously targeting the cholestatic, inflammatory, and fibrotic pathways that drive the progression of complex liver diseases like IFALD. By modulating key biological targets involved in metabolism and signaling, these engineered molecules aim to offer a more potent and targeted therapeutic effect than their natural counterparts.

The success of orziloben would serve as a powerful validation for the entire SEFA platform, potentially unlocking a pipeline of new therapies for other rare liver diseases that share similar underlying pathologies, such as Primary Sclerosing Cholangitis (PSC). The platform’s versatility is a key component of NorthSea’s long-term strategy.

Dr. Vig expressed her confidence in the company's approach. “I am excited to be joining NorthSea’s Board of Directors to help guide development of its innovative pipeline for the benefit of those living with rare liver disease and cholestatic, inflammatory, and fibrotic diseases,” she stated. “I believe that orziloben has the potential to be an effective first-in-class treatment for people living with IFALD.”

Bolstered by substantial Series A and Series B funding rounds from a syndicate of top-tier life science investors including Forbion, venBio, and Novo Seeds, NorthSea appears well-capitalized to push orziloben through its late-stage hurdles. With a seasoned commercialization expert now on board, a promising lead asset targeting a market with no competition, and a pivotal data release on the horizon, all eyes in the rare disease space will be on NorthSea Therapeutics in the coming months.