Gilead and Novo Nordisk have planned a new phase 2b trial in a bid to expand their clinical collaboration in non-alcoholic steatohepatitis (NASH).
The two companies first announced their collaboration in 2019, focused on testing a combination of Gilead’s investigational FXR agonist cilofexor and ACC inhibitor firsocostat with Novo’s GLP-1 receptor agonist semaglutide.
Semaglutide is already approved to control blood glucose levels in adults with poorly controlled type 2 diabetes.
The newly-announced phase 2b trial expands on a previous proof-of-concept study investigating semaglutide, alone and in combination with cilofexor and/or firsocostat, in 108 people with NASH and mild-to-moderate fibrosis.
This study met its primary endpoint, with post-hoc analyses of exploratory efficacy endpoints assessing biomarkers of liver health at 24 weeks showing statistically significant improvements in hepatic steatosis and liver injury in the combination treatment groups versus semaglutide alone.
Now, Gilead and Novo want to build on the findings from their phase 2a trial, by testing a semaglutide alongside a fixed-dose combination of cilofexor and firsocostat in NASH patients with cirrhosis.
The four-arm study is set to evaluate the treatments’ impact on liver fibrosis improvement and NASH resolution, with recruitment into the study expected to begin in the second half of 2021.
“NASH is a disease with a high unmet medical need, as no drugs are currently approved to treat this potentially life-threatening condition,” said Martin Holst Lange, executive vice president and head of development at Novo Nordisk.
“Building on the positive results from our proof-of-concept trial, we hope together with Gilead to demonstrate the potential for semaglutide with cilofexor and firsocostat to help people living with NASH,” he added.
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.
“Gilead is pleased to expand our collaboration with Novo Nordisk and advance understanding of the potential for combination approaches in treating people living with cirrhosis due to NASH,” said Mark Genovese, senior vice president, inflammation clinical development at Gilead Sciences.
“This study is the latest example of our persistent focus on driving innovation to improve the lives of people living with liver diseases and fibrosis,” he added.