Biotech Values

[DewDiligence]

ABBV/ENTA’s Global Phase-3 Program for ABT-493/ABT-530

[Updated for inclusion of CERTAIN-1/2, EXPEDITION-2, and MAGELLAN-2; and major changes to ENDURANCE-3.]


There are ten phase-3 trials with a total of approximately 2,500 patients at clinical-trial sites in about 30 countries; all of these trials are expected to report data in late 2016 or 1H17.


• ENDURANCE-1—620 non-cirrhotic GT1 patients; 8-week and 12-week arms; expected completion Jan 2017:
https://www.clinicaltrials.gov/ct2/show/NCT02604017

• ENDURANCE-2—320 non-cirrhotic GT2 patients; 12-week arms (delayed-start control arm for safety comparison); expected completion Dec 2016:
https://www.clinicaltrials.gov/ct2/show/NCT02640482

• ENDURANCE-3—460 treatment-naïve non-cirrhotic GT3 patients; 8-week and 12-week arms for ABT-493/ABT-530; 12-week Sovaldi/Daklinza comparator arm; expected completion Dec 2016:
https://www.clinicaltrials.gov/ct2/show/NCT02640157

• ENDURANCE-4—130 non-cirrhotic GT4/GT5/GT6; single 12-week arm; expected completion Jun 2016:
https://www.clinicaltrials.gov/ct2/show/NCT02636595

• EXPEDITION-1—175 Child-Pugh A cirrhotic patients of all genotypes except GT3; single 12-week arm; expected completion Sep 2016:
https://www.clinicaltrials.gov/ct2/show/NCT02642432

• EXPEDITION-2—150 patients with HCV/HIV co-infection; 8-week and 12-week arms; expected completion Jan 2017:
https://www.clinicaltrials.gov/ct2/show/NCT02738138

• EXPEDITION-4—100 patients with renal impairment (including cirrhotics); single 12-week arm; expected completion Oct 2016:
https://www.clinicaltrials.gov/ct2/show/NCT02651194

• MAGELLAN-2—70 patients who underwent liver/kidney-transplants; single 12-week arm; expected completion Mar 2017:
https://www.clinicaltrials.gov/ct2/show/NCT02692703

• CERTAIN-1—245 Japanese patients with any genotype; 8-week and 12-week arms (including an arm for renally-impaired patients); expected completion May 2017:
https://www.clinicaltrials.gov/ct2/show/NCT02707952

• CERTAIN-2—120 Japanese GT2 patients; 8-week ABT-493/ABT-530 arm vs 12-week Sovaldi/ribavirin arm; expected completion Dec 2016:
https://www.clinicaltrials.gov/ct2/show/NCT02723084