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 |
Target(s) | Bet v 1 |
Indications of clinical studies | Allergic Rhinitis Conjunctivitis, Allergy |
Primary therapeutic area | Immune-mediated / inflammatory disorders |
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 | 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/ |
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.
Anticipated events | None |
Factor(s) contributing to discontinuation | None |