GENFIT: Cymabay Phase 2 data: read-across for RESOLVE-IT?

Dear investor,
 
In reaction to the confusion generated by Cymabay's Phase 2b announcement earlier today, we would like to bring to your attention a few important points:
 
- Reduction of liver fat content measured by MRI-PDFF or any other means is not considered by regulators as relevant for approval in NASH
 
- Approval is based on "NASH resolution without worsening of fibrosis" solely defined with "hepatocyte ballooning” and “lobular inflammation”, through histological examination irrespective of steatosis evolution
 
- According to this definition, in a 52w Phase 2b trial, elafibranor achieved “NASH Resolution without worsening of fibrosis”, and its on-going Phase 3 trial RESOLVE-IT will readout by year-end, after 72w, on the same regulatory endpoint
 
- Elafibranor (dual PPARa/d agonist) activates complementary pathways via alpha and delta (eg. inflammation), and it has shown positive activity on HbA1c, HDL, insulin sensitivity
 
As a reminder, we believe elafibranor is uniquely positioned in NASH with the potential to become the first monotherapy to be approved by the FDA and the EMA for “NASH resolution without worsening of fibrosis” (ballooning = 0; inflammation = 0 or 1). Phase 2b data published in Gastroenterology, by Ratziu, in May 2016, have shown elafibranor’s unique potential to combine:
 
- efficacy on the regulatory endpoint, approved for Phase 3 trials, that is related to the underlying cause of disease progression to cirrhosis or cancer;
 
- improvement of the cardiometabolic risk profile (reduction of LDL and TG, increase of HDL, and improvement of insulin sensitivity);
 
- favorable safety and tolerability profile.
 
If the molecule’s beneficial activity is confirmed in Phase 3 – the duration of which is 6 months longer than the Phase 2 – elafibranor would be ideally positioned to be prescribed as first line treatment in monotherapy against NASH and as backbone of future combination therapy.
 
It is also important to realize that while fat is playing a role during the onset of NASH, evolution of fat composition is more important than just fat quantity. In line with this, GENFIT has recently launched a Phase 2 trial to evaluate elafibranor’s impact on hepatic lipid composition for NAFL.

To read more Press Release articles, click here.