Updated the 27 of october 2017

In this figure, only phases 3 are included.

At start we have : 

  • Safety announced for ELAFIBRANOR and CENICRIVIROC  is based on absence of bad signals on medium sized trials ( more than 100 patients treated)
  • SELONSERTIB need to proof its safety because of the very small samples of patients treated in the Ph2 trial and also because of the questions on carcino problems evoqued for ASK1
  • OCALIVA safety problem in PBC is now announced by the FDA itself, not sure that the safety can impact NASH patients, but the doubt is there now!   

To complete ! 

Last results of CENICRIVIROC Ph2 trial at 2 years  are not good at all !

Last published results from GILEAD on GS 0976 ( ex Nimbus apollo program) are not very good, steatosis decrease, but only one fibrosis marker improved 0n three .. moreover, triglycerid increase was over 10%. 

GILD annonce that they will exclude from future GS 0976 trials the NASH patients with hyper triglyceridemia, but regarding the lasts publications on the subject it is more than 80% of NASH patients ! it is not a good news !

Comorbidities are important in NASH so the improvements, or worsening, of those comorbidities induced by the compounds should be mentionned as they can impact strongly the final prescription.

Combo are still presented as the NASH treatment GRAAL 

Three of the most advanced compounds are targeting Fibrosis as main endpoint, Elafibranor is the only one targeting mainly metabolic NASH, arging that if the metabolic cause is cured, the fibrosis reduction should follow ! 

Because of its safety, Elafibranor is mentionned by KOLS as the potential first line treatment in NASH, which could include patients with no fibrosis (F0). 

In a combo perspective the 3 compounds targeting fibrosis have no reasons to be associated with each others, but all of them could be associated with Elafibranor !

to follow ...

G Divry

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