Biotech Values

[DewDiligence]

ABBV/ENTA’s Global Phase-3 HCV Program

[Updated for change in expected completion of TURQUOISE-2
from Dec 2013 to Jan 2014 (This does not affect the timing of
the planned NDA submission in 2Q14).]


ABBV/ENTA have 9 global phase-3 trials testing an all-oral
regimen in HCV genotype-1a/1b : 6 trials that comprise the initial
NDA/MAA submissions in 2Q14, and 3 trials for subsequent use.
(MALACHITE-1 and MALACHITE-2 are essentially phase-4 trials
that have been listed as phase-3.)

All 9 of these global phase-3 trials include the 3-DAA combination
of the protease inhibitor, ABT-450/r (licensed by ABBV from ENTA);
the NS5A inhibitor, ABT-267 (from ABBV’s pipeline); and the non-
nucleoside polymerase inhibitor, ABT-333 (from ABBV’s pipeline).
Some of these trials also include ribavirin in one or both trial arms.

SAPHIRE-1 and SAPHIRE-2 are essentially safety studies, as
explained in #msg-91739317.

(ABBV/ENTA are testing the 2-DAA regimen of ABT-450/r + ABT-267
in a phase-3 trial for genotype-1b patients in Japan [#msg-91870291]
and in various phase-2 trials globally.)


Six phase-3 trials comprising initial NDA/MAA submissions:

SAPPHIRE-1—(see #msg-91739317 for discussion)—treatment-naïve GT1a/1b w/o cirrhosis; ABT-450/r + ABT-267 + ABT-333 + ribavirin for 12w vs. identical regimen delayed by 12 weeks of placebo use; 600 patients; expected completion Sep 2013:
http://www.clinicaltrials.gov/ct2/show/NCT01716585

SAPPHIRE-2—(see #msg-91739317 for discussion)—treatment-experienced GT1a/1b w/o cirrhosis; ABT-450/r + ABT-267 + ABT-333 + ribavirin for 12w vs. identical regimen delayed by 12 weeks of placebo use; 400 patients; expected completion Sep 2013:
http://www.clinicaltrials.gov/ct2/show/NCT01715415

PEARL-2—treatment-experienced GT1b w/o cirrhosis; ABT-450/r + ABT-267 + ABT-333 ± ribavirin for 12w; 210 patients; expected completion Mar 2014:
http://www.clinicaltrials.gov/ct2/show/NCT01674725

PEARL-3—treatment-naïve GT1b w/o cirrhosis; ABT-450/r + ABT-267 + ABT-333 ±ribavirin for 12w; 400 patients; expected completion Dec 2013:
http://www.clinicaltrials.gov/ct2/show/NCT01767116

PEARL-4—treatment-naïve GT1a w/o cirrhosis; ABT-450/r + ABT-267 + ABT-333 ±ribavirin for 12w; 300 patients; expected completion Dec 2013:
http://www.clinicaltrials.gov/ct2/show/NCT01833533

TURQUOISE-2—DAA-naïve GT1a/1b with cirrhosis; ABT-450/r + ABT-267 + ABT333 + ribavirin for 12w vs. identical regimen for 24w; 380 patients; expected completion Jan 2014:
http://www.clinicaltrials.gov/ct2/show/NCT01704755


Three phase-3 trials not part of initial NDA/MAA submissions:

TURQUOISE-1—DAA-naïve GT1a/1b with HIV co-infection; ABT-450/r + ABT-267 + ABT333 + ribavirin for 12w vs. identical regimen for 24w; 300 patients; expected completion Dec 2014:
http://clinicaltrials.gov/ct2/show/NCT01939197

MALACHITE-1—5-arm trial including 3 DAA arms and 2 control arms—treatment-naïve GT1a/1b; ABT-450/r + ABT-267 + ABT-333 + ribavirin for 12w vs. Incivek + peg-IFN + ribavirin for 12w plus an additional 12w or 36w of peg-IFN/ribavirin on a response-guided basis; separate DAA and control arms for GT1a and GT1b; additional DAA arm for GT1b without ribavirin; 314 patients; expected completion Jul 2015:
http://www.clinicaltrials.gov/ct2/show/NCT01854697
(Note: This is essentially a phase-4 trial.)

MALACHITE-2—treatment-experienced GT1a/1b; ABT-450/r + ABT-267 + ABT-333 + ribavirin for 12w: vs. Incivek + peg-IFN + ribavirin for 12w plus an additional 12w or 36w of peg-IFN/ribavirin on a response-guided basis; 150 patients; expected completion Jul 2015:
http://www.clinicaltrials.gov/ct2/show/NCT01854528
(Note: This is essentially a phase-4 trial.)