CEO Today Healthcare Awards 2023 - 32 - - NETHERLANDS - NorthSea is a clinical-stage biopharmaceutical company focused on the development of structurally engineered fatty acids, or SEFAs. We are developing SEFAs as a novel class of drugs that are engineered to unlock the therapeutic potential of fatty acids by increasing organ-specificity and minimizing their natural propensity to be incorporated into complex lipids or broken down and used as an energy source. Our proprietary SEFAs have the therapeutic potential to simultaneously target multiple metabolic and inflammatory drivers of disease. Non-Alcoholic SteatoHepatitis (NASH) is the leading cause of liver disease affecting an estimated 15-30 million patients in the US, western Europe and Japan. Today the treatment options available to NASH patients are limited. Our lead product candidate, icosabutate, is a oncedaily, oral SEFA currently in a Phase 2b clinical trial, which we refer to as the ICONA trial, for the treatment of non-alcoholic steatohepatitis, or NASH. In a pre-specified interim analysis of this trial, icosabutate demonstrated dose-dependent and significant improvements that we believe are clinically meaningful in all liver function parameters as well as inflammatory and fibrotic biomarkers. Additionally, patients treated with icosabutate showed significant improvements in lipid profile and glycemic control, demonstrating the potential for icosabutate to address common co-morbidities associated with NASH, such as cardiovascular disease and diabetes. In the ICONA trial, icosabutate has been observed to be generally well-tolerated, with no serious safety signals to date, a key attribute for patients with NASH, who require chronic therapy. Based on the totality of the interim ICONA data, together with our preclinical and other clinical data, we believe icosabutate has the potential to be the preferred backbone therapy for the treatment of NASH, either as a monotherapy or as a combination therapy. In addition to icosabutate, we are developing two additional SEFAs for the treatment of metabolic diseases. SEFA-1024 is an oral, highly lipophilic SEFA that is designed to target the gut-liver axis and to concurrently improve plasma lipids and glycemic control. We have concluded a Phase 1 clinical trial of SEFA-1024 in healthy volunteers and plan to start Phase 2 in 2023. We plan to initially develop SEFA-1024 for the treatment of severe hypertriglyceridemia, or SHTG. We are also developing SEFA-6179, a novel, oral, fully synthetic medium chain fatty acid analogue, for the treatment of intestinal failure-associated liver disease, or IFALD, a rare liver disease affecting individuals on prolonged parenteral nutrition. We have concluded a Phase 1 clinical trial and plan to initiate Phase 2 in 2023. CEO of NorthSea Therapeutics ROB DE REE www.northseatherapeutics.com Prior to joining NorthSea Therapeutics B.V., Rob de Ree served as the CEO of the start-up companies Dezima Pharma, which was acquired by Amgen in 2015 and as the CEO of BMEYE which was acquired by Edwards lifesciences in 2012. Before that Rob de Ree served as the head of the licensing business of Crucell and in various national and international sales and marketing roles at Medtronic. Rob de Ree started his career in pharma in 1991 in sales and marketing at the cardiovascular division of Byk Gulden in the Netherlands. In addition Rob de Ree is currently a board member at Ventinova (chair) and Mellon medical and operating partner at Biogeneration Ventures. Rob de Ree holds an MSc in pharmacy from the University of Groningen. ABOUT ROB DE REE FIRM PROFILE LEADERSHIP EXCELLENCE IN BIOTECHNOLOGY
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