ENYO Pharma SA announces successful completion of EYP001 first in man Phase 1 study

Lyon, June 14, 2017 – ENYO Pharma SA, a privately held biopharmaceutical company currently focused on developing treatments for viral infections, today announced that the Phase 1a single and multiple ascending dose trial evaluating EYP001 in healthy subjects has been completed. The results show that EYP001 was safe and well-tolerated at all doses studied in 80 subjects. The safety, pharmacokinetics (PK) and pharmacodynamic (PD) analysis are in line with established FXR biology and reported results from other early stage compounds that are in development for NASH. In particular, the levels and pattern of plasma concentrations changes of C4 (7αhydroxy4cholesten3one) and fibroblast growth factor 19 (FGF19) are consistent with FXR agonism over the dose range of 60mg up to 500mg of multiple single doses administered over 15 days. These clinical results were presented at the international liver conference in Amsterdam earlier this year. In addition, in vitro data were presented confirming that EYP001 inhibits HBV particle release similarly to Tenofovir (TFV) or Entecavir (ETV), with an additive effect when combined. Moreover, EYP001 alone inhibited viral protein (HBsAg and HBeAg) production, reduced cccDNA and pgRNA, while TFV or ETV mono-treatment had negligible effect on these HBV markers in vitro.

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