ENTA addendum re HBV—The patients in the EDP-514 trial reported on today were nuke-suppressed, which means they had very low viral loads at baseline. That’s why the mean reduction in HBV RNA from baseline was only 1.0 logs (at 28 days) in the EDP-514 arms. We’ll find out how effective EDP-514 monotherapy is at lowering viral load (DNA and RNA) in the separate phase-1b trial ENTA is conducting in viremic HBV patients. In the trial reported on today, the aim is to show safety, tolerability, and PK suitability for qD dosing.
For ENTA’s HBV program as a whole, the goal is to find an all-oral cocktail that provides a functional cure. No other company is attempting to do this, AFAIK, and the upside if ENTA is successful will be colossal. ENTA hopes that a combination of EDP-514 + EDP-721 + a generic nuke (tenofovir or entecavir) will do the trick.
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