About NorthSea Therapeutics
NorthSea is a clinical-stage biopharmaceutical company focused on the development of structurally engineered fatty acids, or SEFAsr the t Non-Creatment of metabolic diseases. 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. Our lead product candidate, icosabutate, is a once-daily, 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. We anticipate final data from the ICONA trial in Q1 2023. 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 H1 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 H1 2023.
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