Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Anti C1q Antibody, Tanruprubart
ANX005 · 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...
ANX005 is an investigational therapy developed by Annexon, Inc. for complement-mediated neurological and autoimmune conditions. It has been studied in Guillain-Barre Syndrome, amyotrophic lateral sclerosis, Huntington disease, and warm autoimmune hemolytic anemia. It is not approved and remains in clinical development.
ANX005 targets C1q, a protein in the complement system. By binding C1q, ANX005 is designed to inhibit the classical complement pathway, which is implicated in nerve damage and autoimmune destruction in the conditions it is being studied for.
ANX005 is being developed by Annexon, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker ANNX. Annexon is the sponsor of the clinical trials evaluating ANX005 in neurological and autoimmune indications.
ANX005 is in Phase 2 development overall, with a completed Phase 3 trial in Guillain-Barre Syndrome and completed Phase 2 trials in amyotrophic lateral sclerosis, Huntington disease, and warm autoimmune hemolytic anemia. It is investigational and has not been approved by the FDA.
ANX005 has been evaluated in completed trials including NCT04701164 in Guillain-Barre Syndrome, NCT04691570 in warm autoimmune hemolytic anemia, NCT04569435 in amyotrophic lateral sclerosis, and NCT04514367 in Huntington disease. These studies enrolled a combined total of 256 participants across multiple countries.
ANX005 was studied in Guillain-Barre Syndrome in the Phase 3 trial NCT04701164, which enrolled 242 participants in Bangladesh and the Philippines. The trial has been completed. ANX005 is investigational and is not an approved treatment for Guillain-Barre Syndrome.