Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Adimanebart IV
Adimanebart · 2 trials · 4 indications
The 6-minute walk test (6MWT) measures the distance a participant walks in 6 minutes.
AE: adverse event; SAE: serious adverse event
AUC0-inf = area under the concentration-time curve from time 0 to infinity
| Arm | Type | Description |
|---|---|---|
| Double-blinded treatment period (DBTP) - Adimanebart IV | EXPERIMENTAL | Participants randomized to receive Adimanebart IV |
| Double-blinded treatment period (DBTP) - Placebo IV | PLACEBO_COMPARATOR | Participants randomized to receive Placebo IV |
| Open-label extension (OLE) - Adimanebart IV | EXPERIMENTAL | Participants receive Adimanebart IV |
| Part 1 - Adimanebart IV | EXPERIMENTAL | Participants randomized to receive adimanebart IV |
| Part 1 - Adimanebart SC (formulation A) | EXPERIMENTAL | Participants randomized to receive adimanebart SC |
| Part 2 - Adimanebart SC (formulation A) in lower body weights | EXPERIMENTAL | Participants with body weight \< 60 kg will receive adimanebart SC |
| Part 2 - Adimanebart SC (formulation A) in higher body weights | EXPERIMENTAL | Participants with body weight between 100 and 130 kg will receive adimanebart SC |
| Part 3 - Adimanebart SC (formulation B) | EXPERIMENTAL | Participants randomized to receive adimanebart SC formulation B |
| Part 3 - Adimanebart SC (formulation C) | EXPERIMENTAL | Participants randomized to receive adimanebart SC formulation C |
| Name | Type | Description |
|---|---|---|
| Adimanebart IV | BIOLOGICAL | Intravenous infusion of Adimanebart |
| Placebo IV | OTHER | Intravenous infusion of Placebo |
| Adimanebart SC - formulation A | BIOLOGICAL | Subcutaneous administration of Adminanebart SC |
| Adimanebart SC - formulation B | BIOLOGICAL | Subcutaneous administration of Adminanebart SC |
| Adimanebart SC - formulation C | BIOLOGICAL | Subcutaneous administration of Adminanebart SC |
Inclusion Criteria: DBTP: * At least 12 years of age. * Has a diagnosis of DOK7-, MUSK-, AGRN-, or LRP4-CMS with documented mutations. * Participants taking oral beta agonists (eg, albuterol, salbutamol, ephedrine) or other CMS medication must have been receiving the medication for at least 6 mont...
Adimanebart is an investigational monoclonal antibody being studied for congenital myasthenic syndrome (CMS), specifically in adult and pediatric participants with DOK7-, MUSK-, AGRN-, or LRP4- CMS. It is also being studied in healthy volunteers to assess its bioavailability and how it moves through the body.
Adimanebart is a monoclonal antibody, but its specific molecular target has not been disclosed in the available information. It is being investigated for congenital myasthenic syndrome, a group of inherited neuromuscular disorders.
Adimanebart is being developed by argenx SE, a biopharmaceutical company traded on the stock exchange under the ticker ARGX. The company is conducting clinical trials to evaluate the drug's safety and efficacy.
Adimanebart is in Phase 3 clinical development for congenital myasthenic syndrome. It is also being studied in a Phase 1 trial in healthy volunteers. The drug is investigational and has not been approved by regulatory authorities.
Adimanebart is being studied in two clinical trials. NCT07673601 is a Phase 1 study in healthy volunteers in Canada, assessing absolute bioavailability. NCT07746089 is a Phase 3 study in patients with congenital myasthenic syndrome, evaluating efficacy and safety.
Yes, Adimanebart is also known as Adimanebart IV. The name Adimanebart IV refers to the intravenous formulation of the drug, which is being studied in clinical trials for congenital myasthenic syndrome.