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REGN727

Phase 1

Hypercholesterolemia | Small molecule | Metabolic |Regeneron Pharmaceuticals, Inc.|Last Updated: Jan 27, 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-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment72
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01161082Ascending Multi-dose Study of REGN727(SAR236553) With and Without Concomitant AtorvastatinPHASE1 COMPLETED 72 — — Jun 1, 2010May 1, 2011Jan 27, 20152 United States
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Study Endpoints
Primary Endpoints
The primary endpoint in the study is to assess the incidence and severity of treatment-emergent adverse events in hyperlipidemic patients treated with REGN727 or placebo receiving stable doses of atorvastatin.
visit 4 (day 1) to visit 16 (day 148)
Secondary Endpoints
To assess the pharmacodynamic effect of REGN727 added to atorvastatin on lipids
Visit 4 (Day 1) to Visit 16 (Day 148)
To assess the pharmacodynamic effect of monotherapy REGN727 in hyperlipidemic patients
Visit 4 (Day 1) to Visit 16 (Day 148)
To assess the pharmacokinetics of REGN727 in hyperlipidemic patients with or without atorvastatin
Visit 4 (Day 1) to Visit 16 (Day 148)
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Group 1 with atorvastatinEXPERIMENTALDose 1 versus placebo
Group 2 with atorvastatinEXPERIMENTALDose 1 versus placebo
Group 3 with atorvastatinEXPERIMENTALDose 2 versus placebo
Group 4 with atorvastatinEXPERIMENTALDose 2 versus placebo
Group 5 with atorvastatinEXPERIMENTALDose 3 versus placebo
Group 6 with atorvastatinEXPERIMENTALDose 3 versus placebo
Group 7 without atorvastatinEXPERIMENTALDose 3 versus placebo
Group 8 with atorvastatinEXPERIMENTALDose4 versus placebo
Interventions
NameTypeDescription
REGN727(SAR236553)DRUGsubcutaneous
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria * Men and women with elevated cholesterol on stable doses of atorvastatin 10-40mg/day regimen * Body mass index between 18.0 and 35.0 kg/m2, inclusive * For women of childbearing potential, a negative serum pregnancy test at the screening visit and a negative urine pregnancy test...

Countries:United States
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