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Re: Jake2234 post# 2436

Monday, 04/03/2023 4:00:04 PM

Monday, April 03, 2023 4:00:04 PM

Post# of 3058
Re: PRDS’ PBI-0451 trial vs ENTA’s EDP-235 trial

Look at prds pbo arm.

Yes, the placebo-arm patients in PRDS’ trial recovered from COVID quickly. This can be attributed, in part, to the trial’s including only vaccinated patients. ENTA’s EDP-235 phase-2 trial includes both vaccinated an unvaccinated patients.

EDP-235 will not show clinical or statistical significance.

ENTA's phase-2 trial, which has two active doses (200mg and 400mg), is not powered to show that either dose of EDP-235 had a statsig benefit vs placebo in the infections virus assay (IVA), the viral load, or time to relief of symptoms. The primary endpoint of the trial is safety. In other words, what constitutes a clinically meaningful outcome in ENTA's EDP-235 trial does not necessarily require statistical significance.

https://www.clinicaltrials.gov/ct2/show/NCT05616728

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