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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 botulinum toxin therapy being developed by AEON Biopharma, Inc. for neurologic conditions. It is in Phase 2 clinical development for cervical dystonia and migraine prevention. ABP-450 has been studied in placebo-controlled, double-blind, randomized trials.
ABP-450 is being evaluated as a treatment for cervical dystonia, a neurologic movement disorder. Two completed Phase 2 trials studied ABP-450 in adults with cervical dystonia, including a repeat-treatment extension study. Both trials enrolled adults 18 years and older in the United States.
ABP-450 is a botulinum toxin therapy. Botulinum toxin works by blocking acetylcholine release at neuromuscular junctions, which reduces muscle contraction. This mechanism underlies its evaluation in cervical dystonia and migraine prevention.
ABP-450 is being developed by AEON Biopharma, Inc., which trades under the ticker AEON. The company is advancing the asset in neurology, with cervical dystonia and migraine as its lead indications.
ABP-450 is in Phase 2 clinical development. It is investigational and has not been approved by the FDA. All three of its listed trials are completed Phase 2 studies, and no active trials are currently listed.
ABP-450 has been studied in three completed Phase 2 trials. NCT04849988 and NCT04871451 evaluated ABP-450 in cervical dystonia in the United States. NCT04845178 studied ABP-450 for migraine prevention in adults across the United States, Australia, and Canada, enrolling 797 participants.