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ABP-450

Phase 2

Cervical Dystonia | Small molecule | Neurology |AEON Biopharma, Inc.|Last Updated: Aug 22, 2024

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials2
Total Enrollment112
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04871451Extension Study of ABP-19000 to Evaluate Safety and Efficacy of Repeat Treatments of ABP-450 in Cervical DystoniaPHASE2 COMPLETED 51 — — Jul 27, 2021Jul 24, 2023Aug 22, 202420 United States
NCT04849988A Phase 2 Study to Evaluate the Safety and Efficacy of ABP-450 in the Treatment of Cervical DystoniaPHASE2 COMPLETED 61 — — Mar 29, 2021Jul 11, 2022Feb 14, 202421 United States
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Study Endpoints
Primary Endpoints
Number of Participants With Treatment-related Serious Adverse Events
Up to 52 weeks

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.

Secondary Endpoints
Mean Change in Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Total Score
Four weeks after the dose of each cycle (4 cycles)
Mean Change in the Subscale Score of Severity of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS)
Four weeks after the dose of each cycle (4 cycles)
Mean Change in the Subscale Score of Disability of the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) Spasmodic Torticollis Rating Scale (TWSTRS)
Four weeks after the dose of each cycle (4 cycles)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ABP-450 - Between Low Dose and High DoseEXPERIMENTALABP-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 DoseEXPERIMENTALABP-450 Low Dose - Intramuscular injections into affected neck muscles.
ABP-450 - Medium DoseEXPERIMENTALABP-450 Mid Dose - Intramuscular injections into affected neck muscles.
ABP-450 - High DoseEXPERIMENTALABP-450 High Dose - Intramuscular injections into affected neck muscles.
PlaceboPLACEBO_COMPARATORPlacebo (0.9% saline, sterile, unpreserved, USP/Ph.Eur.) - Intramuscular injections into affected neck muscles.
Interventions
NameTypeDescription
ABP-450DRUGABP-450 (prabotulinumtoxinA) contains a 900kDA botulinum toxin type-A complex produced by the bacterium Clostridium botulinum.
PlaceboDRUG0.9% sodium chloride, sterile, unpreserved, USP/Ph.Eur.
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites20

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...

Countries:United States
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