Fish oil pill for NASH? Dutch biotech scores $40M injection to make a mark in the bustling field
If Amarin’s fish oil pill is anything to go by, Dutch drug developer NorthSea Therapeutics is in for a ride in its quest to market its own omega 3 drug.
NorthSea’s compound, icosabutate, was in-licensed from Norway’s Pronova BioPharma — the developer of the blockbuster omega 3 cardiovascular drug Omacor that was swallowed by German chemicals giant BASF in 2013.
Akin to Amarin’s pill, icosabutate was originally tested as a treatment for hypertriglyceridemia. NorthSea is focused on testing it for NASH, a fatty liver disease, which has lured an army of drug developers but is a field littered with failure.
On Wednesday, NorthSea secured $40 million in Series B financing, led by venBio Partners, for its shot at the lucrative market that so far has no approved drugs, but is expected to eclipse $20 billion by 2025.
The funds will be used to complete an ongoing Phase IIb NASH study, which is expected to be completed by 2021, as well as the development of two other omega 3 compounds for use in dyslipidaemia and an orphan liver condition called PNALD (parenteral nutrition associated liver disease) respectively.
Non-alcoholic steatohepatitis, or NASH, is characterized by a buildup of excess fat in the liver that induces chronic inflammation and eventually culminates in scarring that can lead to cirrhosis, liver failure, cancer and/or death. Dubbed the silent disease, it is hard to diagnose in the early stages, making it difficult to estimate its prevalence, but studies show that it afflicts up to 12% of the adult population in developed countries.
The first wave of NASH drug developers have struggled with efficacy as well as safety. Companies big and small have crashed and burned. Major contender Intercept Pharmaceuticals’ drug obeticholic acid, the only therapy so far with established antifibrotic activity, is plagued by tolerability limitations. Gilead has little to show for its efforts, and France’s Genfit is expected to come out with its Phase III interim results in the next few months.
Genfit has underscored its drug’s ability to lower cardiovascular risk — the leading cause of mortality in NASH patients are CV events. NorthSea chief Rob de Ree is also gunning to prove his compound has a beneficial impact on the heart, given its previous testing in triglycerides.
“We have shown in over 200 patients in the lipid study that the (drug’s) safety has an excellent profile as well…having shown that we can reduce triglycerides; that we also can reduce cholesterol in this patient population is very important — most of these (NASH) patients in stage II or III don’t die of liver disease, but still die of cardiovascular disease,” de Ree said in an interview with Endpoints News. “We believe that we have quite a complete profile and strongly differentiate from the first wave of compounds.”
It is not necessarily a far fetched goal. Amarin’s Vascepa, known chemically as icosapent ethyl, is an omega-3 fatty acid derived from fish oil that was originally endorsed by the US regulator as a treatment for elevated triglycerides. However, last month the FDA sanctioned its use in the blockbuster indication of reducing cardiovascular risk in patients already on statins following a landmark trial — REDUCE-IT — which showed the pill triggered a 25% reduction in the risk for the first occurrence of a major cardio event, and a 26% reduction in a composite endpoint of cardiovascular death, nonfatal heart attack, and nonfatal stroke.
The latest injection for NorthSea included the participation of new investors Sofinnova Investments, and existing investors, Forbion, Novo Seeds, New Science Ventures and BioGeneration Ventures. The company raised €25 million in series A funding back in December 2017.