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Verinurad +Febuxostat

Phase 2

Hyperuricemia | Small molecule | Metabolic |AstraZeneca PLC|Last Updated: Jan 10, 2020

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 Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03118739Intensive Uric Acid Lowering With Verinurad and Febuxostat in Patients With AlbuminuriaPHASE2 COMPLETED 60 — — May 18, 2017Aug 13, 2018Jan 10, 202018 United States
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Study Endpoints
Primary Endpoints
Urinary Albumin to Creatinine Ratio (UACR)
From Baseline to 12 Weeks of Treatment

LS Mean Percentage Change (95% CI) from Baseline in UACR

Urinary Albumin to Creatinine Ratio (UACR) Compared to Placebo
From Baseline to 24 Weeks of Treatment

LS Mean Percentage Change (90% CI) from Baseline in UACR Compared to Placebo

Secondary Endpoints
sUA
From Baseline to 12 Weeks and 24 Weeks of Treatment
eGFR
From Baseline to 12 Weeks and 24 Weeks of Treatment
Serum Creatinine
From Baseline to 12 Weeks and 24 Weeks of Treatment
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Verinurad 9 mg+Febuxostat 80 mgEXPERIMENTALCapsule administered orally, once daily for 24 weeks
PlaceboPLACEBO_COMPARATORCapsule administered orally, once daily for 24 weeks
Interventions
NameTypeDescription
Verinurad 9 mg+Febuxostat 80 mgDRUGCapsule administered orally, once daily for 24 weeks
PlaceboDRUGCapsule administered orally, once daily for 24 weeks
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Eligibility Criteria
Age Range18 Years — 99 Years
SexALL
Healthy VolunteersNo
Study Sites18

Inclusion Criteria: * Serum Uric Acid ≥6.0 mg/dL * eGFR ≥30 mL/min/1.73 m2 * UACR between 30 mg/g and 3500 mg/g inclusive * Diagnosed with T2DM Exclusion Criteria: * Treated with any drug for hyperuricemia in the 6 months preceding randomization.Drugs for hyperuricemia include all XO inhibitors (...

Countries:United States
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