Biotech Values

[DewDiligence]

Update on ENTA’s HBV development plan:

Based on yesterday’s CC, ENTA will not advance the EDP-514/nuc 2-drug combination into phase-2, but rather will look to find a suitable third agent before proceeding.

The rationale for this decision, in part, is the failure of ASMB’s trial of a core inhibitor and a nuke, where almost all patients relapsed after stopping treatment even though they had sustained, undetectable levels of HBV DNA after 12-18 months of treatment.

I knew about ASMB’s failure (#msg-159327881), but I figured ENTA would proceed with the EDP-514/nuc combo anyhow because Jay Luly has always maintained that EDP-514 is considerably more potent than ASMB’s (now defunct) core inhibitor. On yesterday’s CC, Luly countered that, even if the EDP-514/nuc combination were able to induce a functional cure in some patients, it would take too long a treatment period to accomplish the task.

To re-iterate, what ENTA wants is an all-oral regimen that provides a functional cure for a decent proportion of chronic-HBV patients in a short period of time. Such a regimen will require at least three agents (including a generic nucleoside).