Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 1176 |
| INN | Itepekimab |
| Status | Clinical |
| Drug code(s) | REGN3500, SAR440340 |
| Brand name | None |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| 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 | Transgenic mouse (VelocImmune) |
| Target(s) | IL-33 |
| Indications of clinical studies | Chronic Rhinosinusitis Without Nasal Polyps, Bronchiectasis, Chronic Obstructive Pulmonary Disease, Atopic dermatitis, Asthma, Phase 1 in healthy volunteers |
| Primary therapeutic area | Respiratory diseases |
| Most advanced stage of development (global) | Phase 3 |
| Status | Active |
| Start of clinical phase (IND filing or first Phase 1) | August 15, 2016 |
| Start of Phase 2 | March 12, 2018 |
| Start of Phase 3 | December 16, 2020 |
| 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 | Sanofi |
| Comments about company or candidate | Sanofi plans BLA, MAA submissions in COPD in H2 2025, as of Q2 2024 update released July 25, 2024. NCT06208306 Phase 3 in COPD started in Jan 2024. Phase 3 studies for Chronic obstructive pulmonary disease (NCT04751487, NCT04701983) are recruiting as of May 12, 2023 July 2022 corporate presentation: Pivotal data expected in 2024 for non-Type 2 COPD Phase 3 study. NCT04701983 is a Randomized, Double-blind, Placebo-controlled, Parallel Group Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab (Anti-IL-33 mAb) in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease. April 2020: Removed from Sanofi pipeline for atopic dermatis. In June 2019, Regeneron and Sanofi announced that the Phase 2 study in asthma met the primary endpoint of improvement in loss of asthma control when comparing REGN3500 monotherapy to placebo. In the trial, the greatest improvement was observed in patients with blood eosinophil levels ≥300 cells/microliter. Patients treated with Dupixent monotherapy did numerically better than REGN3500 across all endpoints. The combination of REGN3500 and Dupixent did not demonstrate increased benefit compared to Dupixent monotherapy in this trial. NCT03736967 Phase 2 study in atopic dermatitis started in Nov 2018. NCT03387852 Phase 2 in moderate-to-severe asthma; Phase 1 study in patients with mild asthma initiated in the first quarter of 2017; also intended for COPD |
| Full address of company | Tarrytown, New York, United States North America United States of America https://www.regeneron.com/ |
Antibody to an IL-33 receptor being developed for inflammatory diseases. Phase 1 study in healthy volunteers initiated in the third quarter of 2016
| Anticipated events | BLA, MAA submission planned in COPD H2 2025 |
| Factor(s) contributing to discontinuation | None |