Biotech Values

[DewDiligence]

GILD misses in phase-2 for F3/F4 NASH:

https://finance.yahoo.com/news/gilead-announces-topline-results-phase-130000332.html

Gilead Sciences…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.

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 (F3-F4) due to NASH. The selonsertib monotherapy treatment group was discontinued following termination of the previously reported STELLAR trials of selonsertib [#msg-148428748, #msg-146757072].