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PTC124

Phase 2

Duchenne Muscular Dystrophy | Small molecule | Neurology |PTC Therapeutics, Inc.|Last Updated: Jan 14, 2009

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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment38
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00264888Safety and Efficacy Study of PTC124 in Duchenne Muscular DystrophyPHASE2 COMPLETED 38Dec 1, 2005May 1, 2007Jan 14, 20093 United States
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Study Endpoints
Primary Endpoints
Dystrophin expression as assessed by immunofluorescence evaluation of tissue obtained by biopsy of the extensor digitorum brevis (EDB) muscle of the foot or tibialis anterior (TA) muscle of the leg
Secondary Endpoints
Presence of dystrophin mRNA and dystrophin-related proteins on EDB or TA muscle biopsy, muscle function, compliance with treatment, safety and PTC124 pharmacokinetics
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
PTC124DRUG -
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Eligibility Criteria
Age Range5 Years — N/A
SexMALE
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Diagnosis of DMD based on a clinical phenotype presenting by age 5, with increased serum CK and decrease of dystrophin on a muscle biopsy * Presence of a nonsense mutation in the dystrophin gene * Physical examination or radiographic imaging documenting the presence of EDB or ...

Countries:United States
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