Gilead Sciences, Inc. ( GILD Quick Quote GILD - Free Report) announced that it has expanded its collaboration with Denmark-based Novo Nordisk ( NVO Quick Quote NVO - Free Report) to develop treatments for non-alcoholic steatohepatitis (NASH).
The companies will conduct a double-blind, placebo-controlled study to investigate the safety and efficacy of the latter’s semaglutide, a GLP-1 receptor agonist, and a fixed-dose combination of Gilead’s investigational FXR agonist, cilofexor, and investigational ACC inhibitor, firsocostat. The triple combination regimen will be evaluated in a new phase IIb study in NASH patients with cirrhosis.
This four-arm study will begin recruitment in the second half of 2021. It will enroll approximately 440 patients to evaluate the treatments’ impact on liver fibrosis improvement and NASH resolution.
The initiation of the phase IIb study was based on successful results of the phase IIa proof-of-concept study, which evaluated semaglutide, alone and in combination with cilofexor and/or firsocostat, in 108 people with NASH and mild to moderate fibrosis. The study met its primary endpoint, demonstrating that all regimens were well tolerated over 24 weeks. Moreover, post-hoc analyses of exploratory efficacy endpoints assessing biomarkers of liver health at 24 weeks showed statistically significant improvements in hepatic steatosis and liver injury in the combination treatment arms as compared to semaglutide alone.
We remind investors that oral semaglutide is marketed in the EU under the brand name Rybelsus for treating type II diabetes as an adjunct to diet and exercise for adults with uncontrolled conditions.
NASH is a chronic and progressive liver disease characterized by fat accumulation and inflammation in the liver, which can lead to scarring or fibrosis that impairs liver function.
Gilead’s stock has gained 9.9% in the year so far compared with the
industry's growth of 1.1%.
The massive decline in sales of the HCV franchise has prompted the company to focus on the HIV franchise, Yescarta and other newer avenues.
While the NASH market promises potential, it is quite challenging as well.
Intercept Pharmaceuticals’ ( ICPT Quick Quote ICPT - Free Report) obeticholic acid or OCA is also being evaluated for NASH. However, in June 2020, the FDA had issued a Complete Response Letter (CRL) regarding the company’s New Drug Application (NDA) for OCA for the treatment of fibrosis due to NASH.
Viking Therapeutics ( VKTX Quick Quote VKTX - Free Report) is enrolling in the phase IIb VOYAGE study evaluating VK2809 in biopsy-confirmed NASH and fibrosis.
Gilead currently carries a Zacks Rank #3 (Hold). You can see
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