Gilead Sciences Inc. (GILD) said the primary endpoint wasn’t met in the Phase 2 ATLAS study of combination and monotherapy investigational treatments for advanced fibrosis due to non-alcoholic steatohepatitis.
Gilead said no regimen led to a statistically significant increase in the proportion of patients who achieved the primary efficacy endpoint of a greater than or equal to 1-stage improvement in fibrosis without worsening of NASH. But, statistically significant improvements in multiple response measures of fibrosis and liver function were observed in patients treated with a combination of firsocostat and cilofexor, compared with placebo in patients with advanced fibrosis.
The Phase 2 ATLAS study is a randomized, double-blind, placebo-controlled study that evaluated the safety and efficacy of monotherapy and dual combination regimens of cilofexor 30 mg, firsocostat 20 mg and selonsertib 18 mg in patients with advanced fibrosis due to NASH.
Statistically significant improvements in multiple secondary endpoints were observed in patients treated with firsocostat and cilofexor compared with placebo, the company said.
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