Clinical studies

Vonafexor is currently in Phase 2 for Alport syndrome

Phase 2 ALPESTRIA-1 study: Vonafexor Fixed Dose-escalation Safety and Proof-of-concept Study in Patients With at Risk of Progression Alport Syndrome.

Phase 2a LIVIFY study: Safety, Tolerability, Pharmacokinetics and Efficacy of EYP001a in Patients With Nonalcoholic Steatohepatitis (NASH).
Results: The phase IIa LIVIFY trial results show that single daily administration of oral vonafexor, an FXR agonist, leads in the short term to a reduction in liver fat, liver enzymes, fibrosis biomarkers, body weight and abdominal circumference, and a possible improvement in kidney function, while possible mild moderate pruritus (a peripheral FXR class effect) and an LDL cholesterol increase are manageable with lower doses and statins. These results support exploration in longer and larger trials, with the aim of addressing the unmet medical need in NASH.
NCT03812029 ; EudraCT 2018-003119-22
Ratziu et al. (2022) Journal of Hepatology. 78 (3), 479-492.

Phase 1b, open-label: A Phase 1b, open-label multiple dose study to evaluate in healthy and NASH subjects the safety, tolerability, PK and PD of FXR agonist EYP001a.
NCT03976687

Phase 2a, HBV Naïve patients with Vonafexor + PEG-IFN +/- Entecavir: A Phase 2a open-label study of the oral Farnesoid X Receptor (FXR) modulator EYP001a to assess its safety and anti-viral effect in chronic Hepatitis B (CHB) patients in combination with pegylated interferon alpha2a (peg-IFN) alone and with entecavir (ETV).
NCT04365933

Phase 2a, HBV Aviraemic patients with Vonafexor on top of NUCs: A double-blind randomized controlled study in virologically suppressed chronic Hepatitis B patients on stable chronic NA therapy to assess the rate of functional cure with oral FXR-Agonist EYP001a administered on top of NA.
NCT04465916 ; EudraCT 2019-001629-28

Phase 1b, part A: HBV EYP001a vs Entecavir; Part B: EYP001 + Peg-IFN: A randomized, double-blind, placebo-controlled study to determine the safety, tolerability, pharmacokinetics and pharmacodynamics of the FXR-agonist EYP001a in chronically HBV infected subjects.
NCT03272009 ; EudraCT 2017-002211-33

Phase 1a, HBV, Food effect study: A phase 1, open label, randomized; 4-way crossover study in subjects with chronic hepatitis B virus infection to assess pharmacokinetics (fasted/fed), safety, tolerability and pharmacodynamics of single oral doses of Farnesoid X receptor agonist EYP001a.
NCT03320616 ; EudraCT 2016-004713-27

Phases 1b, Healthy volunteers, Entecavir drug interaction study: Phase 1, single-center, open-label, three subsequent dosing periods study to evaluate the drug-drug-interaction (DDI), pharmaco-kinetics (PK) and pharmacodynamics (PD), safety, and tolerability of a single dose of EYP001a combined with ETV in healthy men and women dosed in the morning under fasted conditions.
NCT03469583

Phase 1, Healthy subjects: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Escalating Single- and Multiple-Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of EYP001a in Healthy Male Subjects.
NCT03110276 ; EudraCT 2016-003035-37

Phase 1, Human Mass Balance Study: A Phase 1 study to investigate the absorption, metabolism, and excretion of EYP001a as well as the safety/tolerability of EYP001a following the administration of a single oral dose to healthy male volunteers.
NCT04037618 ; EudraCT 2019-001304-37