Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABP-450 · 3 trials · 2 indications
The primary safety endpoint will be the incidence of treatment-related serious adverse events since the start of treatment by Treatment Group when dosed with ABP-450 between Low Dose and High Dose.
The primary efficacy endpoint will be the change in mean Monthly Migraine Days (MMD) from the 4-week Baseline period to Weeks 21 to 24 Treatment period.
The primary safety endpoint will be the incidence of TEAEs throughout the study when dosed with placebo, ABP-450 (low dose), or ABP-450 (high dose).
| Arm | Type | Description |
|---|---|---|
| ABP-450 - Between Low Dose and High Dose | EXPERIMENTAL | ABP-450 Between Low Dose and High Dose - Intramuscular injections into affected neck muscles with investigator's determined dose within the range of low dose and high dose - 4 injection cycles at 3-month intervals. |
| ABP-450 - Low Dose | EXPERIMENTAL | ABP-450 Low Dose - Intramuscular injections into affected neck muscles. |
| ABP-450 - Medium Dose | EXPERIMENTAL | ABP-450 Mid Dose - Intramuscular injections into affected neck muscles. |
| ABP-450 - High Dose | EXPERIMENTAL | ABP-450 High Dose - Intramuscular injections into affected neck muscles. |
| Placebo | PLACEBO_COMPARATOR | Placebo (0.9% saline, sterile, unpreserved, USP/Ph.Eur.) - Intramuscular injections into affected neck muscles. |
| Name | Type | Description |
|---|---|---|
| ABP-450 | DRUG | ABP-450 (prabotulinumtoxinA) contains a 900kDA botulinum toxin type-A complex produced by the bacterium Clostridium botulinum. |
| Placebo | DRUG | 0.9% sodium chloride, sterile, unpreserved, USP/Ph.Eur. |
Inclusion Criteria: 1. Qualified for and had their initial dose of study drug in the ABP-19000 study. 2. Provided written informed consent to being treated for cervical dystonia with ABP-450. 3. Were a male or female patient between 18 and 75 years of age (inclusive) when they entered the ABP-19000...
ABP-450 is an investigational small molecule being developed for the prevention of migraine in adults and for the treatment of cervical dystonia. It is currently in Phase 2 clinical development and has not been approved by the FDA.
ABP-450 is being developed by AEON Biopharma, Inc., a biopharmaceutical company. The company is publicly traded under the ticker symbol AEON.
ABP-450 is in Phase 2 clinical development. Two Phase 2 studies have been completed, one for migraine prevention and one for cervical dystonia, along with an extension study for cervical dystonia.
ABP-450 has completed three Phase 2 trials. NCT04845178 evaluated migraine prevention in 797 adults. NCT04849988 evaluated cervical dystonia treatment in 61 adults, and NCT04871451 was an extension study of repeat treatments in 51 adults with cervical dystonia.
ABP-450 is the drug being studied in the clinical trials. The extension study NCT04871451 is titled 'Extension Study of ABP-19000 to Evaluate Safety and Efficacy of Repeat Treatments of ABP-450 in Cervical Dystonia,' suggesting ABP-19000 may be an alternative name for ABP-450.