PBI-0451 (Pomotrelvir) Phase 2 Study in Nonhospitalized Symptomatic Adults With COVID-19

Phase 2 Terminated 242 enrolled Pardes Biosciences, Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a phase 2 double-blind, randomized study of PBI-0451(Pomotrelvir) in nonhospitalized symptomatic adults with COVID-19. PBI-0451(Pomotrelvir) is a new chemical entity and inhibitor of the main protease of coronaviruses, including the SARS-CoV-2 that causes COVID-19 disease. This study is designed to evaluate the antiviral activity, safety, and efficacy of orally administered PBI-0451(Pomotrelvir) compared with placebo.

Timeline

Start: 2022-09-21
Primary completion: 2023-01-27
Completion: 2023-04-14

Outcome

Missed primary endpoint

Stopped: “Interim analysis concluded primary endpoint was not met”

paper The primary endpoint, the proportion of subjects with SARS-CoV-2 viral titers below the limit of detection on Day 3 of treatment in the pomotrelvir versus placebo groups, was not met. PMID 38197702 ↗

Publications

Borroto-Esoda K, Wilfret D, Tong X, Plummer A, Kearney B, Kwong AD. SARS-CoV-2 viral dynamics in a placebo-controlled phase 2 study of patients infected with the SARS-CoV-2 Omicron variant and treated with pomotrelvir. Microbiol Spectr. 2024 Feb 6;12(2):e0298023. doi: 10.1128/spectrum.02980-23. Epub 2024 Jan 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pomotrelvir	Small molecule	700 mg	Oral