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REGN1908-1909

Phase 3

Cat Allergy | Small molecule | Immunology |Regeneron Pharmaceuticals, Inc.|Trials Updated: Jul 1, 2021

REGN1908-1909 development status

Highest phase Phase 3 (NCT04981717)
Phase scored for REGNPhase 2
Registered trials 4 across 1 sponsor since Aug 2013

REGN1908-1909 target and mechanism

Molecular targetFelD1
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials3
Total Enrollment154

FDA Designations

No designations recorded

REGN1908-1909 clinical trials

REGN1908-1909 · 3 trials · 3 indications

Phase 2 1Phase 1 2
NCT03838731Study in Cat-Allergic Patients With Asthma to Evaluate the Efficacy of a Single Dose of REGN1908-1909 to Reduce Bronchoconstriction Upon Cat Allergen ChallengeCat Allergy
COMPLETED56 Analytics
PHASE2COMPLETED
Study in Cat-Allergic Patients With Asthma to Evaluate the Efficacy of a Single Dose of REGN1908-1909 to Reduce Bronchoconstriction Upon Cat Allergen Challenge
Cat AllergyUnlock trial analytics

Study Endpoints

Primary Endpoints

Time to Early Asthmatic Response (EAR) Upon Controlled Cat Allergen Challenge in an Environmental Exposure Unit (EEU) on Day 8
Day 8

Time to EAR was defined as the time to a ≥20% reduction in FEV1 or when the participant voluntarily departed the EEU due to clinically significant allergic and/or asthmatic symptoms.

Change in allergic symptom scale score
At day 8

The primary endpoint is the change in allergic symptom scale score at day 8

Safety
day 1 to day 113

The primary endpoint is to assess treatment-emergent adverse events (TEAEs) from day 1 through day 113 (end of study).

Secondary Endpoints

Time to EAR Upon Controlled Cat Allergen Challenge in an EEU on Days 29, 57, and 85
Days 29, 57 and 85
Percent Change in Normalized Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1) Induced by a Controlled Cat Allergen Challenge Over Exposure Interval From Baseline to Controlled Cat Allergen Challenge on Days 8, 29, 57, and 85
Days 8, 29, 57, and 85
Change in Normalized Area Under the Curve (AUC) of Forced Expiratory Volume in 1 Second (FEV1) Induced by a Controlled Cat Allergen Challenge Over Exposure Interval From Baseline to Controlled Cat Allergen Challenge on Days 8, 29, 57, and 85
Days 8, 29, 57, and 85
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
REGN1908-1909EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Group AEXPERIMENTALParticipants in group A will receive REGN1908-1909
Group BEXPERIMENTALParticipants in group B will receive placebo
Cohort 1EXPERIMENTALDose 1 of REGN1908-1909 or placebo
Cohort 2EXPERIMENTALDose 2 of REGN1908-1909 or placebo
Cohort 3EXPERIMENTALDose 3 of REGN1908-1909 or placebo

Interventions

NameTypeDescription
REGN1908-1909DRUGSingle subcutaneous (SC) dose of REGN1908 and REGN1909
PlaceboDRUGSingle subcutaneous (SC) dose of matching placebo
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Key Inclusion Criteria: * Documented or patient reported history (for at least 2 years) of symptomatic cat allergen-triggered asthma with rhinitis with or without conjunctivitis * No cat exposure at home for the past year and must continue having no exposure at home during the study; cat exposure o...

Countries:FranceNetherlandsNew ZealandSwedenUnited KingdomUnited States
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Frequently asked questions about REGN1908-1909

What is REGN1908-1909 used for?

REGN1908-1909 is being developed for allergy, specifically cat allergy. It is designed to reduce allergic responses in people sensitized to cat allergen. Clinical studies have also evaluated it in patients with cat allergy and mild asthma to reduce bronchoconstriction after cat allergen challenge.

What does REGN1908-1909 target?

REGN1908-1909 targets FelD1, the major cat allergen protein. By binding FelD1, the drug is intended to block the allergen from triggering allergic reactions in sensitized individuals. This targeted approach distinguishes it from symptomatic allergy treatments that act downstream of allergen exposure.

Who is developing REGN1908-1909?

REGN1908-1909 is being developed by Regeneron Pharmaceuticals, Inc., which trades on Nasdaq under the ticker REGN. Regeneron is the sponsor of the clinical trials evaluating this asset in allergic patients.

What phase is REGN1908-1909 in?

REGN1908-1909 is in Phase 1 development. It is an investigational small molecule and has not been approved by the FDA. The completed trials include Phase 1 and Phase 2 studies, but the asset remains in clinical development.

What clinical trials is REGN1908-1909 in?

REGN1908-1909 has been studied in three completed trials: NCT03838731, a Phase 2 study in cat-allergic patients with mild asthma in France; NCT02127801, a Phase 1 study in allergic adults across the Netherlands, New Zealand, Sweden, and the United Kingdom; and NCT01922661, a Phase 1 study in allergic adults in the United States.