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REGN10933+REGN10987

Phase 1

Healthy | Small molecule | Other |Regeneron Pharmaceuticals, Inc.|Last Updated: Jan 26, 2022

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_CONTROLLED
Total Trials1
Total Enrollment974
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04519437Study Assessing the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Repeated Subcutaneous Doses of Anti-Spike (S) SARS-CoV-2 Monoclonal Antibodies (REGN10933+REGN10987) in Adult Volunteers as Related to COVID-19PHASE1 COMPLETED 974 — — Jul 26, 2020Nov 22, 2021Jan 26, 20227 United States
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Study Endpoints
Primary Endpoints
Incidence of adverse event of special interests (AESIs) that occur within 4 days of study drug administration
Within 4 days postdose at Baseline
Concentrations of REGN10933 in serum over time
Up to 52 weeks
Concentrations of REGN10987 in serum over time
Up to 52 weeks
Secondary Endpoints
Proportion of participants with treatment-emergent adverse events (TEAEs)
Up to 52 weeks
Severity of TEAEs
Up to 52 weeks
Proportion of participants who achieve or exceed target concentration in serum of REGN10933
Up to 52 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
REGN10933+REGN10987EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
REGN10933+REGN10987DRUGAdministered subcutaneous (SC) every 4 weeks (Q4W)
PlaceboDRUGAdministered subcutaneous (SC) every 4 weeks (Q4W)
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Eligibility Criteria
Age Range18 Years — 90 Years
SexALL
Healthy VolunteersYes
Study Sites7

Key Inclusion Criteria: 1. Is healthy or has chronic medical condition(s) that is stable and well controlled as per the opinion of the investigator and is not likely to require medical intervention through the end of study 2. Stable medication for co-morbid condition(s) for at least 6 months prior ...

Countries:United States
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