Biotech Values

[oc631]

INHX is running a genotype-2/3 phase-2 trial of INX-189:

On one hand I think this is a good strategy but there are unanswered questions about the efficacy and safety of INX-189/PegRiba in GT1 patients.


What I like about the strategy



- it will fill the hole in GT2/GT3 patient efficacy when combined with a P.I. as a DAA or as quad treatment using PegRiba.

-It should make INX-189 appear to have high efficacy considering they are choosing the easiest to treat class for nukes.


What I don't like



-They still don't have plans to raise the dose in the phase 1b study in GT1's. Why?

Lack of efficacy?
Dose limiting toxicity in combo with PegRiba?
To save money by focusing on GT2/GT3?



-They only mentioned GT1 patients when speaking of future DAA combos sans PegRiba which I thought was strange. Will the FDA allow a Phase 3 DAA combo trial in GT1's without prior mid-stage testing in this subgroup?