TAbS







Atisnolerbart, bremzalerbart, umesolerbart Clinical Mixture of 3

Antibody Information

Entry ID 1187
INN Atisnolerbart, bremzalerbart, umesolerbart
Status Clinical
Drug code(s) REGN5713-5714-5715
Brand name None
mAb sequence source mAb human
General Molecular Category Mixture of 3
Format, general category Full length Ab
Format details None
Isotype (Fc) IgG4
Light chain isotype kappa
Linker None
Ave. DAR None
Conjugated/fused moiety None
Discovery method/technology None

Therapeutic information

Target(s) Bet v 1
Indications of clinical studies Allergic Rhinitis Conjunctivitis, Allergy
Primary therapeutic area Immune-mediated / inflammatory disorders

Development stage information


Most advanced stage of development (global) Phase 3
Status Active
Start of clinical phase (IND filing or first Phase 1) June 03, 2019
Start of Phase 2 January 14, 2021
Start of Phase 3 January 14, 2021
Date BLA/NDA submitted to FDA
Year of first approval (global) None
Date of first US approval
INN, US product name None
US or EU approved indications None

Company information

Company Regeneron Pharmaceuticals
Licensee/Partner None
Comments about company or candidate NCT06602739 Phase 3 of REGN5713 and REGN5715 in Allergic Conjunctivitis due to start in Oct 2024. Listed as Phase 3 asset in company pipeline updated in Feb 2023. NCT04709575 Phase 3 Assessing the Efficacy of Anti-Bet v 1 Monoclonal Antibodies to Reduce Symptoms of Seasonal Allergic Rhinitis started in Jan 2021 completed in Aug 2021. NCT03969849 Phase 1 in healthy subjects started June 3, 2019.
Full address of company Tarrytown, New York, United States
North America
United States of America
https://www.regeneron.com/

Description/comment

Anti-Bet v 1 antibodies designated H4H16992P (also referred to as REGN5713), H4H17038P2 (also referred to as REGN5714) and H4H17082P2 (also referred to as REGN5715); human monoclonal antibodies and antigen-binding fragments thereof that bind birch pollen, e.g. natural Bet v 1.

Additional information

Anticipated events None
Factor(s) contributing to discontinuation None