Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 2416 |
| INN | Suptavumab |
| Status | Terminated |
| Drug code(s) | REGN2222, SAR438584 |
| Brand name | None |
| mAb sequence source | mAb human |
| General Molecular Category | Naked monospecific |
| Format, general category | Full length Ab |
| Format details | None |
| Isotype (Fc) | IgG1 |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | None |
| Discovery method/technology | Transgenic mouse (Velocimmune) |
| Target(s) | RSV (F glycoprotein) |
| Indications of clinical studies | Phase 1 in healthy volunteers, Prevention of Medically Attended RSV Infection in Preterm Infants |
| Primary therapeutic area | Infectious diseases |
| Most advanced stage of development (global) | Terminated at Phase 3 |
| Status | Inactive |
| Start of clinical phase (IND filing or first Phase 1) | December 15, 2013 |
| Start of Phase 2 | |
| Start of Phase 3 | June 01, 2015 |
| 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 | Aug. 14, 2017: Regeneron Pharmaceuticals, Inc. today announced that a Phase 3 study evaluating suptavumab (REGN2222), an antibody to respiratory syncytial virus, did not meet its primary endpoint of preventing medically-attended RSV infections in infants. Suptavumab did show signs of efficacy in a subgroup of patients. Adverse events were generally balanced between suptavumab and placebo. Regeneron plans to discontinue further clinical development of this antibody. NCT02325791 Phase 3 study recruiting as of June 2015. Phase 1 study NCT02121080 completed in March 2015; the antibody was listed as inn Phase 1 in Regeneron 2013 annual report |
| Full address of company | Tarrytown, New York, United States North America United States of America https://www.regeneron.com/ |
Targets the prefusion F protein according to https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8653633/
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |