The two companies intend to collaborate on a clinical trial combining compounds from their respective pipelines in nonalcoholic steatohepatitis (NASH).
The intended clinical trial will be a proof-of-concept study combining Novo Nordisk’s semaglutide (GLP-1 analogue) and Gilead’s cilofexor (FXR agonist) and firsocostat (ACC inhibitor) for the treatment of patients with NASH. The companies are also exploring the potential to collaborate on preclinical research to advance understanding of the disease.
“We are very pleased about the potential to enter into this clinical collaboration with Gilead, which would combine Novo Nordisk’s semaglutide programme in NASH with Gilead’s clinical programmes to provide novel approaches for the treatment of the disease. 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,” said Mads Krogsgaard Thomsen, chief science officer and executive vice president of Novo Nordisk.
NASH is a chronic and progressive liver disease characterised by fat accumulation and inflammation in the liver, which can lead to scarring, or fibrosis, that impairs liver function. If left untreated, individuals living with NASH may face serious consequences, including end-stage liver disease, liver cancer and the need for liver transplantation, and are at a significantly higher risk of liver-related mortality.
Cilofexor and firsocostat, alone or in combination, are investigational compounds and are not approved by the US Food & Drug Administration (FDA) or any other regulatory authority. Safety and efficacy have not been established for these agents. Semaglutide has not been approved by the FDA or any other regulatory authority for the treatment of patients living with NASH.
Photo of Mads Krogsgaard Thomsen: Novo Nordisk