Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TJ003234 · 1 trial · 1 indication
Free of mechanical ventilation was defined as proportion of subjects who scores 1 to 5 in the following 8-category ordinal scale. 8, death; 7, ventilation in addition to extracorporeal membrane oxygen (ECMO), continuous renal replacement therapy (CRRT) or pressors; 6, intubation and mechanical ventilation; 5, non-invasive mechanical ventilation (NIV) or high-flow oxygen; 4, hospitalization with oxygen by mask or nasal prongs; 3. Hospitalization without oxygen supplementation; 2, limitation of activities, discharge from hospital; and 1, no limitation of activities, discharge from hospital.
| Arm | Type | Description |
|---|---|---|
| TJ003234 Medium Dose | EXPERIMENTAL | - |
| TJ003234 Low Dose | EXPERIMENTAL | Part 1 only |
| Placebo | PLACEBO_COMPARATOR | - |
| TJ003234 High Dose | EXPERIMENTAL | Part 2 Phase 3 only |
| Name | Type | Description |
|---|---|---|
| TJ003234 | DRUG | patients receive a single infusion |
| Placebo | DRUG | patients receive a single infusion |
Inclusion Criteria: * Age: 18 years or older (including 18 years); male or female * Laboratory-confirmed SARS-CoV-2 or COVID-19 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay. * Bilateral lung infection confirmed by imaging. * Severe disease th...
TJ003234 was studied as a treatment for severe Coronavirus Disease 2019 (COVID-19). It was evaluated in hospitalized adults with severe COVID-19, a population defined by significant respiratory involvement. The program targeted the infectious disease therapeutic area and was developed by NovaBridge Biosciences.
TJ003234 targets GM-CSF, which stands for granulocyte-macrophage colony-stimulating factor. GM-CSF is a cytokine, a signaling protein involved in immune cell activation and inflammation. By binding GM-CSF, TJ003234 is designed to modulate the inflammatory signaling associated with severe COVID-19.
TJ003234 is being developed by NovaBridge Biosciences, which trades under the ticker NBP. The company sponsored the clinical evaluation of the asset in severe COVID-19. NovaBridge Biosciences holds the development program for this GM-CSF-directed small molecule.
TJ003234 has completed a Phase 2 clinical trial. It is an investigational agent and is not approved for any indication. The Phase 2 study has finished, and no active trials of TJ003234 are currently listed.
TJ003234 was evaluated in the Phase 2 trial NCT04341116, titled Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Subjects With Severe Coronavirus Disease 2019 (COVID-19). The trial enrolled 149 participants in the United States, was randomized, double-blind, and placebo-controlled, and has completed.