GILEAD flunks another NASH study -- Study Prim
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Posted On: 12/16/2019 8:11:38 AM
GILEAD flunks another NASH study
-- Study Primary Endpoint Was Not Met; Improvement in Multiple Measures of Fibrosis and Liver Injury Was Observed with Investigational Firsocostat and Cilofexor --
-- Regimens Were Well Tolerated and Safety Measures Were Consistent with Prior Studies –
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (GILD) today announced topline results from the 48-week, Phase 2 ATLAS study of combination and monotherapy investigational treatments for advanced fibrosis (F3-F4) due to NASH. While no regimen led to a statistically significant increase in the proportion of patients who achieved the primary efficacy endpoint of a ≥1-stage improvement in fibrosis without worsening of NASH, statistically significant improvements in multiple response measures of fibrosis and liver function were observed in patients treated with a combination of the acetyl-CoA carboxylase (ACC) inhibitor firsocostat and the selective, nonsteroidal farnesoid X receptor (FXR) agonist cilofexor, compared with placebo in patients with advanced fibrosis.
-- Study Primary Endpoint Was Not Met; Improvement in Multiple Measures of Fibrosis and Liver Injury Was Observed with Investigational Firsocostat and Cilofexor --
-- Regimens Were Well Tolerated and Safety Measures Were Consistent with Prior Studies –
FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (GILD) today announced topline results from the 48-week, Phase 2 ATLAS study of combination and monotherapy investigational treatments for advanced fibrosis (F3-F4) due to NASH. While no regimen led to a statistically significant increase in the proportion of patients who achieved the primary efficacy endpoint of a ≥1-stage improvement in fibrosis without worsening of NASH, statistically significant improvements in multiple response measures of fibrosis and liver function were observed in patients treated with a combination of the acetyl-CoA carboxylase (ACC) inhibitor firsocostat and the selective, nonsteroidal farnesoid X receptor (FXR) agonist cilofexor, compared with placebo in patients with advanced fibrosis.
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