Biotech Values

[DewDiligence]

Annotations on ABBV/ENTA’s phase-2b dose-finding studies of ABT-493/ABT-530…

• GT1 non-cirrhotic, (treatment-naïve or prior IFN/RBV null responder); 2 open-label 12-week arms (low/high dose of ABT-530); 80 patients (all US sites); expected completion Mar 2015:
http://clinicaltrials.gov/ct2/show/NCT02243280

• GT2/GT3 non-cirrhotic (treatment-naïve or treatment-experienced); 7 open-label 12-week arms (GT2: 3 arms including 2 dosing pairs [1 w RBV]; GT3: 4 arms including 3 dosing pairs [1 with RBV]); 175 patients (locations not specified); expected completion Sep 2015:
http://clinicaltrials.gov/ct2/show/NCT02243293


Discussion: The GT2/GT3 trial is essentially two studies insofar as GT2 and GT3 respond quite differently to most DAAs; many (or most) of the sites in this trial will likely be ex-US (because GT1 is the dominant strain in the US). It’s not immediately clear why the GT1 trial is accepting treatment-experienced patients only if they were null responders to IFN/RBV. I presume that there will be a separate ABT-493 + ABT-530 trial for cirrhotics (as was done with ABBV/ENTA’s 3-DAA regimen).

Note: ENTA’s decision whether to opt in for US profit sharing with ABBV for the ABT-493 + ABT-530 program must be made soon (#msg-106345712).