Replies to post #171258 on Biotech Values

[DewDiligence]

ABBV’s guidance for NDA/MAA submissions of 3-DAA GT1 regimen is now early 2Q14 (i.e. April); the prior guidance had been simply 2Q14. (Source: ABBV’s JPM webcast.)

[DewDiligence]

ABBV/ENTA report preliminary results from TURQUOISE-1* and CORAL-1‡ studies (revised):

http://finance.yahoo.com/news/enanta-announces-results-turquoise-study-140200834.html

New, detailed results from part one of the Phase 2 portion of AbbVie’s Phase 2/3 open-label study, TURQUOISE-I, showed that patients co-infected with genotype 1 HCV and HIV-1 receiving AbbVie’s investigational treatment and ribavirin (RBV) for 12 weeks or 24 weeks achieved a sustained virologic response rate 12 weeks post-treatment (SVR12) of 93.5 percent (n=29/31) and 90.6 percent (n=29/32), respectively.

Inasmuch as the 12w arm’s SVR12 rate of 93.5% was higher than the SVR12 rate for the 24w arm, 12 weeks of treatment would seem to be sufficient for this patient group.

…results from the first cohort of AbbVie’s ongoing open-label Phase 2 study, CORAL-I, were presented today during an oral session at The Liver Meeting 2014, and published online in The New England Journal of Medicine. These data demonstrated that non-cirrhotic liver transplant patients with recurrent GT1 HCV infection and new to treatment after transplantation achieved a SVR12 rate of 97.1 percent (n=33/34) and a sustained virologic response rate 24 weeks post-treatment (SVR24) of 97.1 percent (n=33/34) after 24 weeks of treatment.

97% is an excellent outcome, of course. There’s no discussion in today’s PR about the results of the 12-week arm or whether any of the 34 patients described above came from the non-ribavirin 24w arm (I suspect not).

Note: The patient populations tested by TURQUOISE-1 and CORAL-1 will not be part of the pending NDA for ABBV/ENTA’s 3-DAA regimen (which has a PDUFA date of 12/21/14); rather, these data will be submitted later in an sNDA.

(TURQUOISE-1 in HIV-HCV co-infection should not be confused with TURQUOISE-2 in cirrhotic patients, which does comprise part of the pending NDA for the 3-DAA regimen.)

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*Randomized phase-2/3 trial testing 3-DAA regimen plus ribavirin in HIV/HCV co-infected GT1 patients for 12w vs 24. (Patients are treated for HIV with either Reyataz or Prezista.) The phase-2 portion of the trial contains 63 patients of the approximately 300 to be enrolled overall; expected completion for the phase-3 portion is Sep 2015 (http://clinicaltrials.gov/ct2/show/NCT01939197 ).

‡Randomized phase-2 trial with three arms testing 3-DAA regimen in liver-transplant recipients for 12w vs 24w with ribavirin and for 24w without ribavirin. 70 patients; expected completion Dec 2015 (http://www.clinicaltrials.gov/ct2/show/NCT01782495 ).

[DewDiligence]

Postscript re ABBV/ENTA’s global 3-DAA program: The MALACHITE-1 and -2 phase-4 trials listed in #msg-94927196, which would have tested ABBV/ENTA’s 3-DAA regimen vs Incivek + PEG/RBV, are now obsolete and won’t be conducted.