Biotech Values

[DewDiligence]

GILD appears to be keeping the phase-2 data on GS-5885 (the NS5A inhibitor) under wraps. However, clinicaltrials.gov shows three phase-2 trials of GS-5885 in a 4-drug oral cocktail* and three other phase-2 trials including GS-5885, GS-9451, and interferon/ribavirin. All of these trials are for genotype-1 patients only.


The three all-oral phase-2 trials with GS-5885 are:

• http://clinicaltrials.gov/ct2/show/NCT01434498 (4-drug combo* in first-line setting for ifn-ineligible)

• http://clinicaltrials.gov/ct2/show/NCT01435226 (4-drug combo* in second-line setting following ifn treatment in first line)

• http://www.clinicaltrials.gov/ct2/show/NCT01353248 (4-drug combo* in first- or second-line setting)

*The four drugs are GS-5885, GS-9451 (a PI), tegobuvir/GS-9190 (a non-nuke), and ribavirin.


The three phase-2 trials with GS-5885 and interferon are:

• http://clinicaltrials.gov/ct2/show/NCT01384383 (IL28B CC patients in first-line setting; some patients also take GS-9451)

• http://clinicaltrials.gov/ct2/show/NCT01371578 (second-line setting; some patients also take GS-9451)

• http://clinicaltrials.gov/ct2/show/NCT01356160 (first- or second-line setting; some patients also take GS-9451)