Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
BGB DXP593 · 2 trials · 1 indication
SARS-CoV-2 viral shedding was measured by reverse transcription-quantitative polymerase chain reaction (RT-qPCR) in nasopharyngeal swab samples.
A TEAE is defined as an adverse event (AE) that had an onset date or a worsening in severity from baseline on or after the administration of study drug and up to 30 days after the dose of study drug
| Arm | Type | Description |
|---|---|---|
| BGB-DXP593 Low Dose | EXPERIMENTAL | Participants will receive BGB-DXP593 on Day 1, and followed up for safety for up to 85 days |
| BGB-DXP593 Medium Dose | EXPERIMENTAL | Participants will receive BGB-DXP593 on Day 1, and followed up for safety for up to 85 days |
| BGB-DXP593 High Dose | EXPERIMENTAL | Participants will receive BGB-DXP593 on Day 1, and followed up for safety for up to 85 days |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo on Day 1, and followed up for safety for up to 85 days |
| BGB-DXP593: Dose Level A | EXPERIMENTAL | Participants will receive BGB-DXP593 10 mg/kg on Day 1 |
| BGB-DXP593: Dose Level B | EXPERIMENTAL | Participants will receive BGB-DXP593 30 mg/kg on Day 1 |
| Name | Type | Description |
|---|---|---|
| BGB-DXP593 | DRUG | Intravenous (IV) infusion administered over 30 to 90 minutes at a dose as specified in the treatment arm |
| Placebo | DRUG | Placebo to match BGB-DXP593 administered as specified in the treatment arm |
| BGB DXP593 | DRUG | Administered intravenously (IV) as specified in the treatment arm |
Key Inclusion Criteria: 1. Laboratory-confirmed severe acute respiratory syndrome (SARS)-CoV-2 infection (positive reverse transcription-polymerase chain reaction \[RT-PCR\] test or other authorized antigen testing methods) in any samples following local practice ≤ 72 hours prior to screening. 2. H...
BGB DXP593 is an investigational small molecule developed by BeOne Medicines Ltd. (ticker ONC) for the treatment of Covid19. It has been studied in two completed clinical trials, a Phase 1 study in healthy participants and a Phase 2 study in participants with mild-to-moderate Covid19. It is not described as approved.
BGB DXP593 was studied for the treatment of Covid19. The Phase 2 trial, NCT04551898, evaluated it in participants aged 18 years and older with mild-to-moderate Covid19 across the United States, Brazil, Mexico, and South Africa. The Phase 1 trial, NCT04532294, was conducted in healthy participants in Australia.
BGB DXP593 is developed by BeOne Medicines Ltd., which trades under the ticker ONC. The company sponsored both clinical trials of the asset, the Phase 1 study in healthy participants and the Phase 2 study in participants with mild-to-moderate Covid19.
BGB DXP593 has reached Phase 2. Two trials have been conducted: a completed Phase 1 study in healthy participants and a completed Phase 2 study in participants with mild-to-moderate Covid19. Both trials are listed as completed, and no trials are currently active.
BGB DXP593 has been evaluated in two completed clinical trials. NCT04551898 was a Phase 2 randomized, double-blind, controlled study of 181 participants with mild-to-moderate Covid19. NCT04532294 was a Phase 1 study of 18 healthy participants in Australia. Total enrollment across both trials was 199.
Yes. BGB DXP593 and BGB-DXP593 refer to the same investigational compound from BeOne Medicines Ltd. The hyphenated form is an alternate spelling of the drug name used in trial listings and publications, and both names identify the same Covid19 asset studied in NCT04551898 and NCT04532294.