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REGN2222

Phase 1

Undisclosed | Small molecule | Other |Regeneron Pharmaceuticals, Inc.|Trials Updated: Nov 4, 2016

REGN2222 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Jul 2016

REGN2222 target and mechanism

Molecular targetrespiratory syncytial virus (RSV)
Target classVirus
ModalitySmall molecule

Also known as REGN2222(SAR438584)

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials2
Total Enrollment160

FDA Designations

No designations recorded

REGN2222 clinical trials

REGN2222 · 2 trials · 1 indication

Phase 1 2
NCT02828397Study of the Blood Concentrations of Two Formulations of REGN2222 in Healthy SubjectsHealthy Volunteers
COMPLETED28 Analytics
NCT02121080Study of the Safety and Tolerability of REGN2222(SAR438584) in Healthy Adult VolunteersHealthy Volunteers
COMPLETED132 Analytics
PHASE1COMPLETED
Study of the Blood Concentrations of Two Formulations of REGN2222 in Healthy Subjects
Healthy VolunteersUnlock trial analytics
PHASE1COMPLETED
Study of the Safety and Tolerability of REGN2222(SAR438584) in Healthy Adult Volunteers
Healthy VolunteersUnlock trial analytics

Study Endpoints

Primary Endpoints

Serum REGN2222 concentration-time curve (AUC)
Day 1 to Day 148 (end of study)
Peak REGN2222 concentration (Cmax)
Day 1 to Day 148 (end of study)
The incidence and severity of treatment-emergent adverse events (TEAEs) in participants treated with REGN2222 or placebo.
from day 1 up to week 20 (EOS)

Secondary Endpoints

Treatment-emergent adverse events (TEAEs) from baseline to the end of the study
Day 1 to Day 148 (end of study)
Presence or absence of anti-drug antibody (ADA)
Day 1 to Day 148 (end of study)
Serum concentration
from day 1 over time up to week 20
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Reference DrugEXPERIMENTALREGN2222 Reference Formulation
Test DrugEXPERIMENTALREGN2222 Test Formulation
Cohort 1EXPERIMENTALDosing regimen 1
Cohort 2EXPERIMENTALDosing regimen 2
Cohort 3EXPERIMENTALDosing regimen 3
Cohort 4EXPERIMENTALDosing regimen 4
Cohort 5EXPERIMENTALDosing regimen 5

Interventions

NameTypeDescription
REGN2222DRUG -
REGN2222(SAR438584)DRUG -
placeboDRUG -
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Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites2

Key Inclusion Criteria: 1. Healthy man or woman aged 18 to 60 years 2. Body weight between 50.0 kg and 95.0 kg, inclusive 3. Willing and able to comply with clinic visits and study-related procedures 4. Provide signed informed consent Key Exclusion Criteria: 1. Hemoglobin not within normal limits...

Countries:United States
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Frequently asked questions about REGN2222

What is REGN2222?

REGN2222 is an investigational small molecule developed by Regeneron Pharmaceuticals, Inc. (ticker REGN) that targets respiratory syncytial virus (RSV). It has been studied in Phase 1 clinical trials in healthy adult volunteers. No approved indication has been established for REGN2222.

What does REGN2222 target?

REGN2222 targets respiratory syncytial virus (RSV), a virus that causes respiratory infections. Its target class is viral. The compound is a small molecule designed to act against RSV. Both completed Phase 1 studies enrolled healthy volunteers rather than patients with active RSV infection.

Who makes REGN2222?

REGN2222 is developed by Regeneron Pharmaceuticals, Inc., which trades under the ticker REGN. The alternative name REGN2222(SAR438584) reflects the same asset, and the SAR prefix indicates a Sanofi collaboration naming convention used for this compound.

What phase is REGN2222 in?

REGN2222 is in Phase 1 development. Two Phase 1 trials have been completed, and no active trials are ongoing. The drug is investigational and has not been approved by the FDA for any indication. Both completed studies were conducted in healthy adult volunteers in the United States.

What clinical trials is REGN2222 in?

REGN2222 has been evaluated in two completed Phase 1 trials. NCT02121080 studied the safety and tolerability of REGN2222(SAR438584) in 132 healthy adult volunteers. NCT02828397 compared blood concentrations of two formulations of REGN2222 in 28 healthy subjects. Both trials were randomized, double-blind, and controlled, enrolling 160 participants total.

Is REGN2222 the same as SAR438584?

Yes, REGN2222 and SAR438584 refer to the same investigational compound, written together as REGN2222(SAR438584). REGN2222 is the Regeneron designation, while SAR438584 is the corresponding Sanofi code. Both names appear in the Phase 1 trial NCT02121080, which studied the drug in healthy adult volunteers.