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USL255

Phase 3

Epilepsy | Small molecule | Neurology |Smith & Nephew SNATS, Inc.|Last Updated: Feb 23, 2015

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_CONTROLLEDBiomarker
Total Trials2
Total Enrollment459
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01191086Open-label Extension Study to Evaluate the Safety of USL255 in Patients With Refractory Partial-onset SeizuresPHASE3 COMPLETED 210 — — Oct 1, 2010May 1, 2014Feb 23, 201568 United States, Argentina +13
NCT01142193Study to Evaluate the Safety and Effectiveness of USL255 in Patients With Refractory Partial-onset SeizuresPHASE3 COMPLETED 249 — — May 1, 2010Jan 1, 2013May 22, 201469 United States, Argentina +14
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Study Endpoints
Primary Endpoints
Evaluate the Safety of USL255 Through the Collection of Adverse Events and Clinical Laboratory Evaluations
Open label treatment of up to 62 weeks
Percent Reduction From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline.
11 weeks
Secondary Endpoints
Proportion of Subjects With ≥50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Plus Maintenance Phase Compared to Baseline.
11 weeks
Proportion of Subjects With ≥50% Reduction (Responder Rate) in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phase Compared to Baseline.
3 weeks (weeks 1-3)
Percent Reductions From Baseline in Weekly (7 Day) Partial-onset Seizure Frequency During the Titration Phase Compared to Baseline.
3 weeks (weeks 1-3)
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Open-label USL255EXPERIMENTALTopiramate extended-release capsules (USL255) up to a maximum of 400 mg per day
USL255EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
USL255DRUG -
PlaceboDRUG -
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites68

Inclusion Criteria: * Have completed the maintenance period of the P09-004 study. * Continue to be treated with a stable dose of 1 to a maximum of 3 approved concomitant AEDs.

Countries:United StatesArgentinaAustraliaBelgiumCanadaChileGermanyGreeceIndiaIsraelNew ZealandPolandRussiaSouth AfricaSpainHungary
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Competitive Landscape -Epilepsy 37 trials
CompanyTickerTrialsLead PhaseDrugs
Xenon Pharmaceuticals Inc.XENE4PHASE3XEN1101
Praxis Precision Medicines, Inc.PRAX6PHASE3vormatrogine, elsunersen, PRAX-628, PRAX-222 - Initial Dose, PRAX-222 - Initial Ascending Doses
Rapport Therapeutics, Inc.RAPP3PHASE3RAP-219
NeuroPace, Inc.NPCE2PHASE3Undisclosed
Supernus Pharmaceuticals, Inc.SUPN4PHASE2SPN-817, BIS-001ER
Biohaven Ltd.BHVN3PHASE2BHV-7000
Harmony Biosciences Holdings, Inc.HRMY1PHASE3Clemizole
Jazz Pharmaceuticals Public Limited CompanyJAZZ3PHASE1CBD-OS, Epidiolex /mL, Epidiolex
Bright Minds Biosciences Inc.DRUG1PHASE2BMB-101
uniQure N.V.QURE1PHASE1AAV9-hSyn1-miGRIK2
Boston Scientific CorporationBSX1NAUndisclosed
Tango Therapeutics, Inc.TNGX1PHASE1S230815- Starting dose A, S230815- Dose B, S230815- Dose C, S230815- Dose D
IQVIA Holdings IncIQV1 — Undisclosed
NeuroOne Medical Technologies CorporationNMTC1 — Undisclosed
Unity Health TorontoUBX1NAUndisclosed
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