Biotech Values

[DewDiligence]

Re: Rationale for ABBV/ENTA’s ENDURANCE-3 trial design

(ENTA)—Abbvie could challenge the…notion that…the best GT3 treatment must be Sovaldi based.

Yes, that seems to be the point of the ENDURANCE-3 study cited in #msg-119485082.

I’m pretty sure the design of ENDURANCE-3 is a business decision by ABBV/ENTA rather than a requirement imposed by regulators. Most phase-3 trials in HCV are either: a) duration-finding studies (e.g. ENDURANCE-1 in GT1 patients, which tests 12w vs 8w: https://www.clinicaltrials.gov/ct2/show/NCT02604017 ); or b) studies where the control arm has a delayed treatment start to enable a safety comparison vs placebo during the on-treatment period for the active arm (e.g. ENDURANCE-2 in GT2 patients: https://www.clinicaltrials.gov/ct2/show/NCT02640482 ). In either of the above cases, the control arm consists of the same drug combination being tested in the “active” arm.