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Re: DewDiligence post# 241635

Tuesday, 09/13/2022 9:58:19 AM

Tuesday, September 13, 2022 9:58:19 AM

Post# of 249869
(ENTA)—PRDS starts phase-2 trial of PBI-0451-vs-placebo in non-hospitalized, high-risk COVID patients:

Pardes Biosciences expects to enroll 210 patients…at approximately 75 sites within the United States. Study eligibility will include symptoms of COVID-19 for 5 or less days and a positive test for SARS-CoV-2 infection. Use of concomitant medications for underlying health conditions will not be restricted in the clinical trial.

Participants will be administered PBI-0451 orally with food, twice daily, at a 700 mg (2x 350 mg tablets) dose or placebo over five days.

The primary objective will be to determine the proportion of patients below the limit of detection in nasal swab samples for infectious SARS-CoV-2 on day three. Secondary objectives will include assessments of safety and tolerability, time to sustained clinical recovery through day 28 defined as key COVID-19 symptoms, and hospitalizations and deaths.

The daily drug burden of 700mg is pretty high because PBI-0451 is a weaker inhibitor of the SARS-CoV-2 protease than ENTA’s EDP-235.

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