Gilead and Novo Nordisk Team up to Tackle NASH

Novo Nordisk logo on white outdoor flag

Gilead Sciences and Novo Nordisk have joined forces to tackle nonalcoholic steatohepatitis (NASH). The companies will collaborate on a clinical trial to combine Novo Nordisk’s semaglutide and Gilead’s cilofexor and firsocostat for the treatment of NASH.

The collaboration was announced as companies from across the globe are presenting data on various liver diseases at the European Association for the Study of the Liver (EASL): The International Liver Congress 2019 in Vienna. NASH is one of the most popular targets for companies at the conference. On Thursday, Gilead presented new proof of concept data that showed positive data from a combination treatment of cilofexor and firsocostat resulted in improvements in hepatic steatosis, liver stiffness, liver biochemistry and serum fibrosis markers.

Foster City, Calif.-based Gilead and Denmark-based Novo Nordisk pointed to the complexities of treating NASH, a disease that has so far stymied researchers in coming up with multiple forms of treatment. Novo Nordisk and Gilead said their collaboration could also take aim at some preclinical research to advance understanding of the progressive liver disease that is characterized by fat accumulation and inflammation in the liver, which can lead to scarring or fibrosis. Financial terms of the collaboration were not disclosed.

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It is estimated that NASH affects more than 16 million people in the U.S. alone. If untreated, NASH patients face serious consequences, including end-stage liver disease, liver cancer and the need for liver transplantation Also, they are at a significantly higher risk of liver-related mortality. Current treatment standards for NASH are lifestyle changes, including diet, weight loss and exercise.

Because of the lack of approved treatments for NASH, it has become a wildly popular target for companies. There are nearly 200 experimental treatments in the pipeline of drugmakers. With the plethora of companies aiming resources at NASH and the increasing growth of the disease, GlobalData has speculated the NASH market will hit $18.3 billion by 2026.

Gilead Chief Scientific Officer John McHutchison pointed to the limited treatments for NASH and said his team is excited to work with Novo Nordisk in developing treatments that will “help address this significant unmet need for patients.” McHutchison said the collaboration pairs Novo Nordisk’s broad expertise related to diabetes and metabolism and Gilead’s expertise in both liver disease and combination therapies.

“We are very pleased about the potential to enter into this clinical collaboration with Gilead, which would combine Novo Nordisk’s semaglutide program in NASH with Gilead’s clinical programs to provide novel approaches for the treatment of NASH. By combining the leading molecular science and clinical expertise of our two companies within the rapidly expanding liver and metabolic diseases, we aim to develop innovative, new and effective combination therapies to help people with NASH,” Mads Krogsgaard Thomsen, Novo Nordisk’s CSO, said in a statement.

While Gilead presented some positive data at the international liver expo this week, the company did see a setback with its late-stage NASH candidate selonsertib in February. The drug failed to hit primary endpoints in its Phase III trial. NASH has become a significant focus for Gilead Sciences. The company has spent a considerable amount of money building up its resources in this space. In January, Gilead acquired global rights to develop and commercialize novel small molecules against two targets from South Korea’s Yuhan Corporation. The month prior, Gilead inked a deal with Cambridge, Mass.-based Scholar Rock to discover and develop highly specific inhibitors of transforming growth factor-beta activation for fibrotic diseases, including NASH.

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