Biotech Values

[DewDiligence]

IDIX:

How would you quantify the importance of such a study? Will efficacy be evaluated or ONLY safety?

This is a PK and drug-drug-interaction (DDI) study, not an efficacy study. My guess is that GSK’s combining IDX899 with Isentress is a prelude to GSK’s combining IDX899 with GSK’s own integrase inhibitor called S/GSK1349572, which is in phase-2 (#msg-46935325).

Since S/GSK1349572 and Isentress are similar drugs, the DDI of IDX899 and Isentress is likely to be similar to the DDI of IDX899 and S/GSK1349572, and it was presumably easier for GSK to get the FDA to permit a DDI study of IDX899 with an approved drug (Isentress) than with an experimental drug (S/GSK1349572).

Another interesting feature of the new study is that it is testing IDX899 at 200mg, which is double the highest dose tested previously by either GSK or IDIX.

All told, it looks like GSK is dead serious about developing IDX899. I think investors can expect an announcement of the start of phase-2b trials soon (#msg-47558107).