French biopharmaceutical company ENYO Pharma is conducting its Phase I single and multiple ascending dose trial of EYP001 to treat Chronic Hepatitis B (CHB) Virus infection.
EYP001 is an orally administered small non-bile acid molecule, impacting the nuclear receptor farnesoid X receptor (FXR).
FXR is a nuclear hormone receptor, also known as the bile acid receptor that controls several metabolic pathways and particularly the bile acids in the liver and intestine.
EYP001 works by affecting the HBV replication in the liver at post-entry steps, which is believed to impact transcriptional activity of covalently closed circular DNA.
Activating the FXR, EYP001 paves the way for efficient suppression of the virus causing the disease.
ENYO Pharma chief medical officer Pietro Scalfaro said: “Several publications with non-clinical models have now pointed strongly to FXR as an important target for HBV infection with the potential to impact disease progression."
The Phase I study has completed its single dose escalation phase, which has examined 46 healthy subjects.
Results suggested the safety and tolerability of EYP001 after it was administered to the subjects.
ENYO Pharma CEO Jacky Vonderscher said: “We are very pleased with the pharmacokinetics and safety profile emerging in our Phase I development with EYP001.
"We look forward to bringing EYP001, our first candidate, into further clinical development and believe we have the potential to become a key player in the field of novel CHBV therapies."
Further analysis of the safety and pharmacokinetics (PK) profile of EYP001 from the Phase I clincial data is expected to be released in the second quarter of next year.
The company has also announced the next Phase I clinical trials of EYP001 to test the safety, PK and initial anti-viral activity of EYP001 in treating chronic HBV infection.