Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Raxibacumab · 1 trial · 1 indication
Number of participants who developed an positive anti-raxibacumab antibody response during the study were assessed.The antibody response to raxibacumab was assessed using a screening assay (i.e. by electrochemiluminescence counts). Positive samples would be further tested in an inhibition of binding assay to confirm the specificity of binding.
| Arm | Type | Description |
|---|---|---|
| Raxibacumab arm | EXPERIMENTAL | A maximum of 25 subjects (to include 3 evaluable female subjects) will receive a second dose of raxibacumab equal to that of the previous dose \>= 4 months following the first dose. |
| Name | Type | Description |
|---|---|---|
| Raxibacumab | BIOLOGICAL | Raxibacumab will be supplied in 50 milliliter (mL) sterile, single-use vials containing 34.9 mL of liquid formulation per vial. Each vial contains 50 milligram (mg)/mL raxibacumab in 0.13 mg/mL citric acid, 2.8 mg/mL sodium citrate, 10 mg/mL sucrose, 18 mg/mL glycine, 0.2 mg/mL polysorbate 80, pH 6.5 |
Inclusion Criteria: * Enrolled and treated with raxibacumab in another HGS protocol, \>= 4 months ago. * Male or female \>= 18 and \<= 64 years of age. * Laboratory values that are Grade 0 by the modified Division of Microbiology and Infectious Diseases (DMID) toxicity tables. Subjects with laborat...
Raxibacumab is a monoclonal antibody being developed for the therapeutic treatment of inhalation anthrax. It is currently in Phase 2 clinical development and is considered investigational, meaning it has not been approved for use.
Raxibacumab is a monoclonal antibody that targets the protective antigen of Bacillus anthracis, the bacterium that causes anthrax. By binding to this antigen, it is designed to neutralize the toxin and help treat inhalation anthrax.
Raxibacumab is being developed by GSK plc, a global pharmaceutical company listed on the stock exchange under the ticker symbol GSK.
Raxibacumab is in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by regulatory authorities and is still undergoing clinical trials to evaluate its safety and efficacy.
Raxibacumab has one completed clinical trial, identified as NCT02016963. This was an open-label, nonrandomized study to evaluate the safety and immunogenicity of Raxibacumab with reinjection, involving 20 healthy volunteers aged 18 years and older.
Raxibacumab is a distinct monoclonal antibody and is not known to be the same as any other drug. It is specifically designed for the therapeutic treatment of inhalation anthrax.