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

Phase lengths*

*The graph represents early-stage clinical development phase lengths. For molecules approved or under evaluation for marketing authorization in the US is provided a complete overview of all clinical development phase lengths. Phase lengths are calculated from the start of the first in human (FIH) study (Start of clinical phase). “Start of Phase 2” bar represents Phase 1 length (Start of clinical phase to start of Phase 2); “Start of Phase 3” bar represents Phase 1+2 length (Start of clinical phase to start of Phase 3); “Date BLA/NDA submitted” bar represents Phase 1+2+3 length (Start of clinical phase to Date BLA/NDA submitted); and “Date of first US approval” bar represents Phase 1 to first US approval length (Start of clinical phase to Date of first US approval).

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