NorthSea Therapeutics Appoints Morris J. Birnbaum to Board

AMSTERDAM–(COMMERCIAL WIRE)–NorthSea Therapeutics BV (“NST”), a biotechnology company developing novel and innovative strategies for the treatment of nonalcoholic steatohepatitis (NASH) and other metabolic diseases, today announces the appointment of Morris J. Birnbaum as an Independent Member of the board

Following a successful academic career studying insulin action and metabolism regulation, Morris J. Birnbaum, MD, PhD, joined Pfizer in 2014 initially as scientific director of the internal medicine research unit. During his years at Pfizer, Morris accumulated extensive experience in the discovery and early-stage clinical development of metabolic diseases. A full biography is in the notes to editors.

NorthSea Therapeutics has three SEFAs (structurally modified fatty acids, a new class of drugs) in clinical development: icosabutate is in phase 2b (ICONA, first line reading at H1-23) and is being developed for NASH. SEFA-1024 is being developed for SHTG (Severe Hypertriglyceridemia). A Phase 1 study was successfully completed in Q4 2020. A Phase 1 study was also successfully completed in Q4-22 for SEFA-6179, and a third SEFA for IFALD (fatty-failure-associated liver disease) is under development. intestinal). Both SEFA-1024 and SEFA-6179 will advance to phase 2 in 2023.

Rob de Ree, CEO of NST, commented: “With the appointment of Morris, we are adding a global healthcare professional to our board. Given his relevant experience in the pharmaceutical industry, his leadership and insights into early and late stage clinical development in the metabolic space will be invaluable to our clinical development programs.”

Morris Birnbaum added: “NST has built an exciting development pipeline with three programs already in the clinic, all of which have great potential for significant medical impact. I am delighted to be joining the Board and will look forward to assisting the leadership team as the programs move toward approval.”

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Notes to editors

About Morris J. Birnbaum

Morris J. Birnbaum, MD, Ph.D. is a physician scientist who has led research teams investigating fundamental issues in metabolic regulation and its relevance to chronic disease in academic and pharmaceutical settings. After a long academic career, in 2014, Dr. Birnbaum moved to Pfizer Inc in Cambridge, MA as Scientific Director of the Internal Medicine Research Unit, where he was responsible for the discovery and early clinical development of drugs designed to treat diseases metabolic disorders such as diabetes, obesity, heart failure and cachexia. Under his leadership, Pfizer has brought seven potential new drugs into clinical development.

Dr. Birnbaum earned his MD and MD from Brown University and completed an Internal Medicine residency at Washington University Barnes Hospital in St. Louis, followed by post-doctoral training at the University of California, San Francisco and the Sloan-Kettering Institute in New York. Dr. Birnbaum has held teaching positions at Harvard Medical School, the University of Pennsylvania Perelman School of Medicine, and the Howard Hughes Medical Institute. He currently serves on the editorial boards of Science Signaling and Cell Metabolism.

About NASH

NASH is a chronic liver disease characterized by inflammation and fibrosis of the liver and represents a more advanced stage of non-alcoholic fatty liver disease (NAFLD). It is frequently associated with obesity and type 2 diabetes and is driven by multiple factors, including the formation of toxic lipid species in the liver, which induces liver inflammation. Further disease progression leads to advanced liver fibrosis and cirrhosis with a high risk of liver failure, hepatocellular cancer, and the need for liver transplantation. It is estimated that 15-30% of the adult population in developed countries have NAFLD, of which 10-15% may progress to NASH, representing at least ~15-30 million patients over the 6 years. main markets.

About icosabutate. Icosabutate, NorthSea Therapeutic’s lead candidate, is an orally administered, structurally modified, liver-targeted eicosapentaenoic acid derivative. The structural modifications result in high hepatic concentrations of unesterified icosabutate which, in turn, optimize the targeting of fatty acid receptors of key importance for NASH, including FFAR4. Preclinical data have demonstrated its therapeutic potential for the treatment of fibrosing NASH and, of relevance to NASH patients, significant improvements in atherogenic lipids, glycemic control, and inflammation have been demonstrated in clinical studies. The potential to target both NASH and its associated comorbidities, together with a favorable safety profile and oral administration, support icosabutate as a potential basic treatment for a wide range of NASH patients.

About North Sea Therapeutics

NorthSea Therapeutics BV (NST) is a Dutch biotechnology company focused on the development of structurally modified fatty acids (‘SEFA’) for the treatment of NASH and other metabolic disorders. NST licensed the rights to its lead compound icosabutate and a SEFA library from Pronova BioPharma Norge AS, which developed Lovaza® (American brand, Omacor brand® in Europe), a highly successful cardiovascular drug. Icosabutate has been found safe and effective in two previous phase 2 clinical studies for the treatment of hypertriglyceridemia and mixed dyslipidemia and is currently in clinical development for NASH. The phase 2b ICONA NASH trial of icosabutate is scheduled for read-out in the first half of 2023. Two additional SEFAs are in clinical development; SEFA-1024 completed in Q4 2022, a Phase 1 study and is being developed for SHTG, and SEFA-6179, completed a Phase 1 study in Q4 2022, is being developed for the IFALD orphan indication liver disease associated with intestinal failure). NST is headquartered in the Netherlands with a presence in Norway and the US and is backed by Ysios Capital, Forbion Growth, Forbion Ventures, Novo Seeds, BGV, NSV, venBio Partners and Sofinnova Investments. Learn more about us online at: www.northseatherapeutics.com

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