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REGN2176-3

Phase 2

Neovascular Wet Age-related Macular Degeneration (AMD) | Small molecule | Ophthalmology |Regeneron Pharmaceuticals, Inc.|Trials Updated: Feb 11, 2015

REGN2176-3 development status

Highest phase Phase 2 (NCT02418754)
Phase scored for REGNPhase 1
Registered trials 2 across 1 sponsor since Feb 2014

REGN2176-3 target and mechanism

Molecular targetPDGFR-beta
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

REGN2176-3 clinical trials

REGN2176-3 · 1 trial · 1 indication

Phase 1 1
NCT02061865Phase 1 Safety Study With Intravitreal (IVT) REGN2176-3 in Patients Aged 50 Years and Older With Wet AMDNeovascular Wet Age-related Macular Degeneration (AMD)
COMPLETED12 Analytics
PHASE1COMPLETED
Phase 1 Safety Study With Intravitreal (IVT) REGN2176-3 in Patients Aged 50 Years and Older With Wet AMD
Neovascular Wet Age-related Macular Degeneration (AMD)Unlock trial analytics

Study Endpoints

Primary Endpoints

Safety
day 1 through week 24

The primary endpoint in the study is the incidence of treatment emergent adverse events (TEAEs) from day 1 through week 24 in patients treated with IVT REGN2176-3.

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Cohorts 1 - 4EXPERIMENTALParticipants in cohort 1 will receive REGN2176-3 dosing regimen 1. Participants in cohort 2 will receive REGN2176-3 dosing regimen 2. Participants in cohort 3 will receive REGN2176-3 dosing regimen 3. Participants in cohort 4 will receive REGN2176-3 dosing regimen 4.

Interventions

NameTypeDescription
REGN2176-3DRUG -
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Eligibility Criteria

Age Range50 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites4

Inclusion Criteria: Key Criteria: Men or women greater than or equal to 50 years of age who provide informed consent and have active subfoveal choroidal neovascularization (CNV) secondary to wet AMD. Exclusion Criteria: 1. Any prior treatment with an inhibitor of PDGF (platelet-derived growth fa...

Countries:United States
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Frequently asked questions about REGN2176-3

What is REGN2176-3?

REGN2176-3 is an investigational small molecule developed by Regeneron Pharmaceuticals for neovascular wet age-related macular degeneration, also known as wet AMD. It was studied as an intravitreal injection in a Phase 1 safety trial in patients aged 50 years and older. It is not an approved therapy.

What is REGN2176-3 used for in wet AMD?

REGN2176-3 was evaluated for the treatment of neovascular wet age-related macular degeneration, a form of AMD marked by abnormal blood vessel growth under the retina. The clinical program studied it in patients aged 50 years and older with wet AMD. It remains investigational and is not approved for any use.

What does REGN2176-3 target?

REGN2176-3 targets PDGFR-beta, a protein receptor. PDGFR-beta is a platelet-derived growth factor receptor that supports the survival and recruitment of cells forming new blood vessels, a process relevant to the vascular pathology of wet AMD. REGN2176-3 is a small molecule directed at this target.

Who is developing REGN2176-3?

REGN2176-3 is being developed by Regeneron Pharmaceuticals, Inc., which trades on Nasdaq under the ticker REGN. Regeneron sponsored the Phase 1 safety study of the compound in patients with wet age-related macular degeneration conducted in the United States.

What phase is REGN2176-3 in?

REGN2176-3 is in Phase 1 development. Its only recorded clinical trial, NCT02061865, was a Phase 1 safety study in patients aged 50 years and older with wet AMD. That trial is completed, and REGN2176-3 is investigational rather than an approved treatment.

What clinical trials is REGN2176-3 in?

REGN2176-3 has been studied in one clinical trial, NCT02061865, titled a Phase 1 safety study with intravitreal REGN2176-3 in patients aged 50 years and older with wet AMD. The trial enrolled 12 patients in the United States, was uncontrolled, and is now completed.