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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 migraine prevention and for the treatment of cervical dystonia. It is in Phase 2 clinical development for both neurological indications.
ABP-450 is being developed by AEON Biopharma, Inc., a biopharmaceutical company. The company's stock is traded under the ticker symbol AEON.
ABP-450 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Clinical trials for migraine and cervical dystonia have been completed.
ABP-450 has completed three Phase 2 trials. NCT04845178 evaluated migraine prevention in 797 adults. NCT04849988 and NCT04871451 evaluated cervical dystonia treatment and repeat treatments, enrolling 61 and 51 adults respectively.
ABP-450 is also known as ABP-19000. An extension study, NCT04871451, evaluated repeat treatments of ABP-450 in cervical dystonia and is listed under the name ABP-19000.