Biotech Values

[DewDiligence]

Is GILD’s GS9190 a serious drug candidate?

[This is a repost of a prior message on this board that contained several typographical errors and was probably posted when I hadn’t had an adequate amount of coffee.]


GILD reported more trouble with its HCV non-nucleoside polymerase inhibitor, GS9190, on the 4Q09 CC this week.

Background: GS9190 is about two years behind its original schedule because a QT-prolongation problem was encountered in phase-1 even at the lowest dose (#msg-24268443). Subsequently, GILD reported that the QT-prolongation issue was “manageable” by lowering the dose further (#msg-26220678); then, in Oct 2008, GILD told investors that GS9190 did not cause a QT-prolongation problem after all (#msg-32919311).

A year later (Oct 2009), GILD announced that GS9190 would not be advanced into phase-3 in conjunction with interferon and ribavirin, but rather would be tested in an all-oral regiment with GILD’s newly disclosed PI called GS9256 (#msg-42717806). However, before these two drugs could be combined in a phase-2 efficacy study, a drug-drug-interaction study was needed to ascertain the proper dosing.

Fast forward to this week: on the 4Q09 CC, GILD said the DDI study showed that GS9256 boosts the effective dose of GS9190, which could lead to unacceptable QT-prolongation!

In other words, GILD has come full circle on the QT-prolongation issue. After dickering with GS9190 for more than three years, GILD still doesn’t have what it considers an acceptable regimen for testing.

Bottom line: I’m finding it hard to take the GS9190 program seriously. I consider this bullish for IDIX and the other companies pursuing HCV nukes and non-nukes.