NorthSea Therapeutics: Biotech startup lines up more cash to steer its NASH drug through stormy seas

In January 2020, Dutch NASH-focused biotech NorthSea Therapeutics raised $40 million in a Series B to progress its lead candidate icosabutate, a structurally-engineered fatty compound for NASH. Just shy of two years later, NorthSea has completed another round of financing, netting a $80 million Series C to start a Phase III in NASH and advance several other candidates. The biotech announced the raise early this morning, which was co-led by Ysios Capital and Forbion Growth, and joined by new investor Hercules Capital. Some of the existing investors that hopped onto the round included Novo Seeds and Sofinnova, according to NorthSea. Started back in late 2017 by ex-Dezima CEO Rob de Ree with just over $28 million in capital to develop an oral drug for NASH, icosabutate - in-licensed from Pronova BioPharma - had already shown to be safe and effective in two previous Phase II clinical trials, NorthSea said back in 2017. Those two trials were for hypertriglyceridemia, a common condition where a high level of triglycerides (a certain type of fat) is present in the blood. NorthSea dosed its first patient in September 2019 as part of the ICONA trial - a 62 week-long, Phase IIb trial testing icosabutate in more than 200 patients. The biotech announced this morning that it just finished enrolling patients for the trial, setting the number at 264. The funds will push forward a few of NorthSea's drug candidates further into clinical trials, it said in a statement. Outside of icosabutate, it has three other programs: SEFA-1024 for dyslipidemia (currently in a Phase I study), SEFA-6179 in a newly-started Phase I trial for intestinal failure associated liver disease and SEFA-6131, which is still in preclinical testing for familial chylomicronemia syndrome, a genetic disorder. The biotech said it will start preparing next year for icosabutate to enter Phase III - in anticipation for top line results from the Phase IIb trial in the first quarter of 2023. Over the last few years, the first wave of NASH drug developers has struggled with both safety and efficacy. When Goldman Sachs predicted that 2019 would be "The Year of NASH," that prediction didn't just fall flat - it sloped downwards as 2019 showed a cacophony of failures in the biotech industry. Gilead failed two large Phase III trials; CymaBay's share price crashed from over $13 a share in early 2019 to under $2 a share after they found their drug appeared to be making patients worse in one study; and Cirius withdrew an $86 million IPO bid after a fateful readout in their massive, 400+ patient Phase IIb trial. Just in 2019. Fast forward to 2020 and 2021, and it's a similar trend. Intercept's drug obeticholic acid has been plagued with different issues: The drug got hit with a CRL in June 2020 for a NASH indication, and was then restricted by the FDA earlier this year in another indication because of severe liver damage in patients with advanced cirrhosis. Genfit threw in the towel last July on NASH after a massive Phase III failure on its drug candidate elafibranor - which ironically was just bought today by fellow French biotech Ipsen in a $575 million deal. While the field of programs dedicated for NASH is littered with failures, that doesn't mean biotechs aren't still trying. GSK paid Arrowhead $120 million upfront and over $900 million in milestones on Arrowhead's RNA drug in November, a risky bet to maybe turn out the first functional NASH drug. All that said, eyes are on NorthSea to see how icosabutate does in Phase II and whether it can do what no other drug has yet - or if it will bite the dust like most of its predecessors.