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 being developed for the treatment of Covid19. It is a neutralizing antibody designed to target SARS-CoV-2, the virus that causes Covid19. The drug is currently in Phase 2 clinical development and has been studied in patients with mild-to-moderate Covid19.
BGB DXP593 targets SARS-CoV-2, the virus responsible for Covid19. It is a neutralizing antibody that binds to the virus to prevent it from infecting cells. This mechanism is intended to reduce viral load and potentially improve clinical outcomes in patients with Covid19.
BGB DXP593 is being developed by BeOne Medicines Ltd., a biopharmaceutical company listed on the stock exchange under the ticker ONC. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for Covid19.
BGB DXP593 is in Phase 2 clinical development for Covid19. It is an investigational drug and has not been approved by regulatory authorities. The Phase 2 trial has been completed, and the drug is no longer in active clinical trials.
BGB DXP593 has been studied in two clinical trials. The first, NCT04532294, was a Phase 1 study in healthy participants in Australia. The second, NCT04551898, was a Phase 2 study in patients with mild-to-moderate Covid19 in the United States, Brazil, Mexico, and South Africa. Both trials are completed.
Yes, BGB DXP593 is also referred to as BGB-DXP593. The drug is a neutralizing antibody being developed by BeOne Medicines Ltd. for the treatment of Covid19. It has been evaluated in clinical trials under both names, with the same mechanism of action targeting SARS-CoV-2.