Enanta Pharmaceuticals Inc (ENTA)

[DewDiligence]

ENTA reports final data from two phase-1b studies of EDP-514 (including 800mg cohorts):

https://www.enanta.com/investors/news-releases/press-release/2021/Enanta-Pharmaceuticals-Reports-Positive-Final-Data-from-its-Phase-1b-Studies-of-EDP-514-a-Novel-Hepatitis-B-Virus-Core-Inhibitor/default.aspx

In the nuke-suppressed phase-1b trial, HBV DNA at baseline is either very low or undetectable in all patients, but HBV RNA is detectable in some patients. However, in the 800mg cohort, 5 of the 6 patients happened to have very low or undetectable HBV RNA at baseline, making the HBV RNA change from baseline to day-28 a meaningless calculation.

In the viremic phase-1b trial, there was a nice dose response in the reduction of HBV DNA from baseline to day-28: -2.9 logs in the 200mg arm; -3.3logs in the 400mg arm; and -3.5 logs in the 800mg arm.

All told, the 400mg dose looks like it provides sufficient pressure on the virus, and it is the most likely dose for ENTA to advance into phase-2, IMO.

I still plan to post the AASLD poster presentations on both phase-1b studies when I obtain them from IR.