Biotech Values

[DewDiligence]

Re: AVIR, ENTA phase-3 trial designs

[AVIR’s trial] is a placebo controlled trial, not a non-inferiority trial in comparison to Paxlovid, the latter being what you suggested ENTA might do for EDP-235.

AVIR’s phase-3 trial is a hybrid: in geographic areas where Paxlovid is available, the trial tests Paxlovid + AT-527 vs Paxlovid; in areas where Paxlovid is unavailable, the trial tests AT-527 monotherapy vs placebo. The primary endpoint is based on the monotherapy portion of the trial.

ENTA will likely be able to run a non-inferiority trial of EDP-235 vs Paxlovid because Paxlovid is sson expected to receive full-fledged FDA approval (rather than a mere EUA), enabling ENTA to obtain Paxlovid through commercial channels for use in the phase-3 trial. AVIR did not have this option when its own phase-3 trial commenced.