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Arhalofenate

Phase 2

Gout | Small molecule | Musculoskeletal |Gilead Sciences, Inc.|Last Updated: Jan 29, 2018

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-BlindACTIVE_CONTROLLEDBiomarker
Total Trials3
Total Enrollment380
FDA Designations
No designations recorded
Clinical Trials (3)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02252835Evaluate the PK, PD, and Safety of Arhalofenate in Combination With Febuxostat for Hyperuricemia in Patients With GoutPHASE2 COMPLETED 32 — — Aug 1, 2014Dec 1, 2014Apr 17, 20151 United States
NCT02063997Evaluate the Efficacy and Safety of Arhalofenate for Preventing Flares and Reducing Serum Uric Acid in Gout PatientsPHASE2 COMPLETED 248 — — Mar 1, 2014Jan 1, 2015Jan 29, 201856 United States, Canada +1
NCT01399008Safety/Efficacy Study to Evaluate of MBX-102 in Combination With Allopurinol in Gout PatientsPHASE2 COMPLETED 100 — — Jun 1, 2011Feb 1, 2012Sep 18, 201524 United States, Canada +1
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Study Endpoints
Primary Endpoints
Proportion of patients achieving a target sUA < 6.0, < 5.0, < 4.0, and < 3.0 mg/dL on Day 29 after treatment with arhalofenate 800 mg and febuxostat 80 mg
Day 29
Proportion of patients achieving an sUA reduction of ≥ 2.0, ≥ 3.0, and ≥ 4.0 mg/dL from baseline on Day 29 after treatment with arhalofenate 800 mg and febuxostat 80 mg
Day 29
Absolute and percent reduction in sUA from baseline on Day 29 after treatment with arhalofenate 800 mg and febuxostat 80 mg
Day 29
AUC(0-t) of arhalofenate 800 mg and febuxostat 80 mg when administered separately and in combination
Days 14, 28, and 42
AUC(0-tau) of arhalofenate 800 mg and febuxostat 80 mg when administered separately and in combination
Days 14, 28, and 42
Tmax of arhalofenate 800 mg and febuxostat 80 mg when administered separately and in combination
Days 14, 28, and 42
Cmax of arhalofenate 800 mg and febuxostat 80 mg when administered separately and in combination
Days 14, 28, and 42
The incidence of flares (mean number of flares per patient) from baseline through Week 12 in the arhalofenate 800 mg group compared to the allopurinol 300 mg group.
12 weeks
Serum Uric Acid
Percent change from baseline in serum uric acid at Week 4

Percent change from baseline in serum uric acid in Per Protocol population

Secondary Endpoints
Proportion of patients achieving a target sUA < 6.0, < 5.0, < 4.0, and < 3.0 mg/dL on Day 29 after treatment with arhalofenate 600 mg and febuxostat 40 mg
Day 29
Proportion of patients achieving an sUA reduction of ≥ 2.0, ≥ 3.0, and ≥ 4.0 mg/dL from baseline on Day 29 after treatment with arhalofenate 600 mg and febuxostat 40 mg
Day 29
Absolute and percent reduction in sUA from baseline on Day 29 after treatment with arhalofenate 600 mg and febuxostat 40 mg
Day 29
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arhalofenate with febuxostat (PK cohort)EXPERIMENTAL -
Arhalofenate with febuxostat (non-PK cohort)EXPERIMENTAL -
Arhalofenate 600 mgEXPERIMENTAL -
Arhalofenate 800 mgEXPERIMENTAL -
Allopurinol 300 mg; colchicine 0.6 mgACTIVE_COMPARATOR -
Allopurinol 300 mgACTIVE_COMPARATOR -
PlaceboPLACEBO_COMPARATOR -
Arhalofenate 400 mgEXPERIMENTALArhalofenate 400 mg plus allopurinol 300 mg
AllopurinolACTIVE_COMPARATORPlacebo plus Allopurinol 300 mg
Interventions
NameTypeDescription
ArhalofenateDRUG800 mg once daily orally for four weeks
FebuxostatDRUG40 mg once daily orally for 1 week then up-titrated to 80 mg once daily orally for another three weeks
ColchicineDRUG0.6 mg daily
Arhalofenate 600 mgDRUGArhalofenate 600 mg tablets once daily for 12 weeks
Allopurinol 300 mgDRUGAllopurinol 300 mg tablets once daily for 12 weeks
Colchicine 0.6 mgDRUGColchicine 0.6 mg over-encapsulated tablets once daily for 12 weeks
PlaceboDRUGPlacebo tablets once daily for 12 weeks
Arhalofenate 800 mgDRUGArhalofenate 800 mg tablets once daily for 12 weeks
AllopurinolDRUGAllopurinol 300 mg as active comparator
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or female patient, 18 to 75 years of age, inclusive * Known gout diagnosis (per criteria of the American Rheumatism Association) * Has an sUA ≥ 7.5 mg/dL * A female patient must be surgically sterile or post-menopausal (at least 45 years of age with no history of menses f...

Countries:United StatesCanadaGeorgia
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Competitive Landscape -Gout 5 trials
CompanyTickerTrialsLead PhaseDrugs
Amgen Inc.AMGN1PHASE3Pegloticase, Methotrexate
Novo Nordisk A/S Sponsored ADR Class BNVO1PHASE1NNC4004-0002
ProtalixPLX1PHASE2PRX-115, Methotrexate
TJ Biopharma Co., Ltd.IMAB1PHASE2Plonmarlimab, Compound betamethasone
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