Enanta Pharma reports encouraging data on HBV and NASH candidates

Data from Enanta Pharmaceuticals’ (NASDAQ:ENTA) development programs for non-alcoholic steatohepatitis (NASH) and hepatitis B virus (HBV) will be virtually presented at the European Association for the Study of the Liver Annual Meeting.

Results from the Phase 1a clinical trial of EDP-514, a core inhibitor for HBV will be presented. Its NASH program will be discussed in an oral presentation detailing the Phase 2a ARGON-1 study of EDP-305 and two posters highlighting preclinical data on EDP-297, a follow-on FXR agonist.

The first-in-human Phase 1a study of EDP-514, demonstrated strong safety, tolerability and pharmacokinetic profile, which will help to further advance HBV program into two ongoing Phase 1b clinical studies.

The Phase 2a ARGON-1 study’s primary endpoint was achieved with a statistically significant alanine transaminase reduction of 28 U/L in the EDP-305 2.5mg arm versus 15 U/L in the placebo arm at week 12 (p=0.049).

Reduction in liver fat was also observed at the 2.5mg dose. Strong target engagement as shown by reductions in C4 and increases in FGF-19 and alkaline phosphatase was also seen.

Overall, EDP-305 was generally safe, with mild to moderate adverse events. However, there was a higher frequency of treatment discontinuation in 2.5mg dose compared to the 1mg or placebo.

Preclinical data for follow-on FXR Agonist EDP-297 targeting NASH demonstrated potent anti-fibrotic, anti-inflammatory and hepatoprotective effects.

Here are some of the other companies presenting at the Conference: Eiger BioPharmaceuticals (NASDAQ:EIGR), Adaptimmune (NASDAQ:ADAP), Arrowhead Pharmaceuticals (NASDAQ:ARWR), Intercept Pharmaceuticals (NASDAQ:ICPT), NGM Biopharmaceuticals and Viking Therapeutics.

https://seekingalpha.com/news/3609694-enanta-pharma-reports-encouraging-data-on-hbv-and-nash-candidates