Gilead Sciences, Novo Collaborate To Study Efficacy Of Cilofexor, Firsocostat In NASH Patients

(RTTNews) - Gilead Sciences, Inc. (GILD) and Novo Nordisk A/S (NOVO B) Thursday said the companies have expanded their clinical collaboration in non-alcoholic steatohepatitis or NASH, a chronic and progressive liver disease that causes fat accumulation and inflammation in the liver that impairs liver function.

NASH is a potentially life-threatening disease condition with a high unmet medical need, as no drugs are currently approved to treat this.

The companies will investigate the safety and efficacy of Novo Nordisk's semaglutide, a GLP-1 receptor agonist, and a fixed-dose combination of Gilead's investigational FXR agonist cilofexor and investigational ACC inhibitor firsocostat, alone and in combination in people with compensated cirrhosis due to NASH.

The new Phase 2b study is based on positive results from a Phase 2a proof-of-concept study in 108 people with NASH and mild to moderate fibrosis. The study using cilofexor and/or firsocostat met a primary endpoint and was well tolerated.

The four-arm study will enroll around 440 patients will evaluate the treatments' impact on liver fibrosis improvement and NASH resolution.