Gilead, Novo Nordisk To Test Triple Combo Therapy In New NASH Study

Gilead Sciences Inc GILD and Novo Nordisk A/S NVO have expanded their clinical collaboration in non-alcoholic steatohepatitis (NASH).

• The companies will conduct a Phase 2b study of Novo Nordisk's semaglutide and a fixed-dose combination of Gilead's cilofexor and firsocostat, alone and in combination in people with compensated cirrhosis due to NASH.
• The four-arm study in approximately 440 patients will evaluate the treatments' impact on liver fibrosis improvement and NASH resolution. Patient recruitment will start in the second half of 2021.
• This new Phase 2b study builds on results from a Phase 2a proof-of-concept study presented at Liver Meeting Digital Experience in November last year investigating semaglutide, alone and in combination with cilofexor and 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. The most common adverse events were gastrointestinal. Across all groups, 5–14% of people discontinued any trial treatment due to adverse events.
• Also, post-hoc analyses of exploratory efficacy endpoints assessing liver health biomarkers at 24 weeks showed statistically significant improvements in hepatic steatosis and liver injury in the combination treatment arms versus semaglutide alone.
• Price Action: NVO shares are trading 0.81% lower at $71.2 in premarket on the last check Thursday, while GILD shares closed 0.6% higher at $64.42 on Wednesday.