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Triheptanoin oil

Phase 2

Huntington Disease | Small molecule | Rare Disease |Ultragenyx Pharmaceutical Inc.|Last Updated: Jul 15, 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_CONTROLLED
Total Trials1
Total Enrollment100
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02453061A Comparative Phase 2 Study Assessing the Efficacy of Triheptanoin, an Anaplerotic Therapy in Huntington's DiseasePHASE2 COMPLETED 100Jun 29, 2015Dec 3, 2019Jul 15, 20242 France, Netherlands
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Study Endpoints
Primary Endpoints
volumetric magnetic resonance imaging
6 months

A decrease in the rate of caudate atrophy, using volumetric MRI

Secondary Endpoints
motor function after 6 months
6 months
31- Phosphorus Magnetic Resonance Spectroscopy
3 months
Caudal Atrophy
12 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Placebo groupPLACEBO_COMPARATORSubjects will receive safflower oil at 1g/kg/day for 6 months (months 0 - 6) and triheptanoin oil at 1g/kg/day for 6 months (months 7 - 12)
Triheptanoin groupACTIVE_COMPARATORSubjects will receive triheptanoin oil at 1g/kg/day for 6 months (months 0 - 6) and triheptanoin oil at 1g/kg/day for 6 months (months 7 - 12)
Interventions
NameTypeDescription
Triheptanoin oilDRUGTriheptanoin oil orally administered at 1g/kg/day
PlaceboDRUGSafflower oil orally administered at 1g/kg/day
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Positive genetic test with CAG repeat length ≥39 in HTT gene * At least 18 years of age * Signature of informed consent * Covered by social security * UHDRS score between 5 and 40 * Ability to undergo MRI scanning * BMI between 18 and 30 Exclusion Criteria: * Hypersensitivit...

Countries:FranceNetherlands
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Competitive Landscape -Huntington's Disease 9 trials