Gilead Sciences has announced its intent to initiate a clinical collaboration with Novo Nordisk for a trial combining compounds from their respective pipelines in nonalcoholic steatohepatitis (NASH).
The announcement comes just days after the company presented new NASH data at the 2019 International Liver Conference, announcing results from its small midstage, proof-of-concept trial, combining two of Gilead’s NASH asset – a selective, non-steroidal farnesoid X receptor (FXR) agonist cilofexor (aka GS-9674, from its Phenex buy) and the acetyl-CoA carboxylase (ACC) inhibitor firsocostat (aka GS-0976, which came from its Nimbus deal).
The new combination saw improvements in hepatic steatosis, liver stiffness, liver biochemistry and serum fibrosis markers, showing “a significant decline of at least 30% in hepatic fat measured by magnetic resonance imaging-proton density fat fraction (MRI-PDFF) from baseline to 12 weeks in 74% of patients”, the Biotech said, with “improvements in liver biochemistry tests including serum ALT (median relative reduction, -37%; p<0.001) and GGT (-32%; p<0.001), along with markers of reduced bile acid synthesis, were observed at 12 weeks.”
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 the disorder, as well as exploring the potential to collaborate on preclinical research to advance understanding of the disease.
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. Currently, patients living with NASH have limited treatment options.