Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as ANX005
Tanruprubart · 6 trials · 5 indications
Number participants recently diagnosed with GBS who experience adverse events.
An adverse event (AE) was any untoward medical occurrence in a participant who had been administered a pharmaceutical product. An AE did not necessarily have a causal relationship with the product and therefore could be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a pharmaceutical product. An AE could arise with any use, route of administration, formulation, dose (including an overdose), or when used in combination with another pharmaceutical product. A TEAE was an AE with an onset date/time after the first infusion of ANX005 until the end of the study. A summary of serious and all other non-serious adverse events regardless of causality is located in the Adverse Events module.
Maximum change from Baseline was calculated as the maximum post-Baseline value observed up to Day 71 minus the Baseline value. Baseline was defined as the last non-missing observation recorded before the first dose of ANX005.
Change from Baseline was calculated as the post-Baseline value at Day 71 minus the Baseline value. Baseline was defined as the last non-missing observation recorded before the first dose of ANX005.
Change from Baseline was calculated as the post-Baseline value at Day 71 minus the Baseline value. Baseline was defined as the last non-missing observation recorded before the first dose of ANX005.
Change from Baseline was calculated as the post-Baseline value at Day 71 minus the Baseline value. Baseline was defined as the last non-missing observation recorded before the first dose of ANX005.
Change from Baseline was calculated as the post-Baseline value at Day 71 minus the Baseline value. Baseline was defined as the last non-missing observation recorded before the first dose of ANX005.
Change from Baseline was calculated as the post-Baseline value at Day 71 minus the Baseline value. Baseline was defined as the last non-missing observation recorded before the first dose of ANX005.
As measured by incidence of TEAEs, SAEs, AE's related to ANX005, SAE's related to ANX005, Grade 3 or higher AEs, Grade 3 or higher AEs related to ANX005, AEs leading to study or treatment discontinuation.
| Arm | Type | Description |
|---|---|---|
| Tanruprubart | EXPERIMENTAL | Participants will receive a single 30 mg/kg intravenous (IV) infusion of tanruprubart on Day 1. |
| ANX005 Treatment Group - Dose 1 | EXPERIMENTAL | Participants will receive a single IV infusion of ANX005 (Dose 1) on Day 1. |
| ANX005 Treatment Group - Dose 2 | EXPERIMENTAL | Participants will receive a single IV infusion of ANX005 (Dose 2) on Day 1. |
| Placebo Group | PLACEBO_COMPARATOR | Participants will receive a single IV infusion of placebo on Day 1. |
| ANX005 | EXPERIMENTAL | Participants will receive two once-weekly doses of ANX005 at specific time points |
| Open Label Treatment Arm | EXPERIMENTAL | One (1) dose of ANX005, 75 mg/kg, will be administered IV. IVIg, 0.4 g/kg, will be administered for 5 consecutive Days. |
| Name | Type | Description |
|---|---|---|
| Tanruprubart | DRUG | Solution for IV infusion. |
| ANX005 | DRUG | Solution for intravenous infusion |
| Placebo | DRUG | Solution for intravenous infusion |
| Intravenous immunoglobulin | DRUG | investigational drug |
Key Inclusion Criteria: * Diagnosis of GBS according to the National Institute of Neurological Disorders and Stroke Diagnostic Criteria for GBS. * Onset of GBS-related weakness ≤10 days before start of infusion on Day 1 * GBS-disability score (DS) score of 3, 4, or 5 at screening and before start o...
Tanruprubart is an investigational small molecule being developed for the treatment of Guillain-Barre Syndrome, a neurological disorder. It is currently in Phase 3 clinical development and has not been approved by the FDA. The drug has received Fast Track and Orphan Drug designations from the FDA.
Tanruprubart targets C1q, a protein involved in the complement system, which is part of the immune response. By targeting C1q, the drug aims to modulate the immune system's activity in Guillain-Barre Syndrome. This mechanism is being studied in an ongoing Phase 3 clinical trial.
Tanruprubart is being developed by Annexon, Inc., a biopharmaceutical company listed on the stock exchange under the ticker symbol ANNX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with Guillain-Barre Syndrome.
Tanruprubart is currently in Phase 3 clinical development. It is an investigational drug, meaning it has not been approved by the FDA for commercial use. The drug has received Fast Track and Orphan Drug designations, which are intended to expedite its development and review process.
Tanruprubart is being studied in an open-label, uncontrolled Phase 3 clinical trial with the identifier NCT07020819, known as the FORWARD Study. This trial is recruiting participants with Guillain-Barre Syndrome in the United States and Denmark, with a planned enrollment of 30 participants aged 12 years and older.
Yes, Tanruprubart is also commonly known as ANX005. The clinical trial NCT07020819, which evaluates the drug in Guillain-Barre Syndrome, explicitly refers to Tanruprubart as ANX005. Both names refer to the same investigational drug being developed by Annexon, Inc.