Biotech Values

[DewDiligence]

It's newsworthy ABBV[/ENTA] is running a Phase-3 [Japan] study in GT2 patients.

Yes, it is newsworthy; neither company had previously disclosed the intention of conducting a Japanese phase-3 in GT2, although they had mentioned the GT1b study on several occasions. I presume the GT2 trial was kept under wraps for competitive reasons.

How many GT2 patients have been treated with the 2-DAA combo? What were the SVR rates?

Don’t know the answers for the reason mentioned above.

Would this study be enough for GT2 labeling in Japan?

Good question; the size and open-label design of GIFT-2 make it more like a phase-2b trial than a typical phase-3.