Database for
Therapeutic Antibodies
Therapeutic Antibodies
| Entry ID | 497 |
| INN | Dapirolizumab pegol |
| Status | Clinical |
| Drug code(s) | CDP-7657 |
| Brand name | None |
| mAb sequence source | mAb humanized |
| General Molecular Category | Immunoconjugate, Pegylated |
| Format, general category | Fragment conjugate |
| Format details | Fab, pegylated |
| Isotype (Fc) | None |
| Light chain isotype | kappa |
| Linker | None |
| Ave. DAR | None |
| Conjugated/fused moiety | PEG |
| Discovery method/technology | Rat B cell derived |
| Target(s) | CD40L |
| Indications of clinical studies | Systemic Lupus Erythematosus |
| 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) | March 15, 2010 |
| Start of Phase 2 | June 15, 2016 |
| Start of Phase 3 | August 12, 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 | UCB Biopharma |
| Licensee/Partner | Biogen |
| Comments about company or candidate | Nov 2024: In the NCT04294667 Phase 3 PHOENYCS GO SLE study, dapirolizumab pegol met its primary endpoint, demonstrating statistically and clinically significant improvement across all organ systems as measured by BICLA, an endpoint measuring disease activity. In 2024, UCB and Biogen will initiate a second Phase 3 trial of dapirolizumab pegol, PHOENYCS FLY (NCT06617325). NCT06617325 Phase 3 in SLE due to start in Oct 2024. Topline results in NCT04294667 Phase 3 PHOENYCS GO SLE study expected mid-year 2024. NCT04976322 is enrolling by invitation as of July 2023. NCT04294667 Phase 3 study in SLE started in Aug 2020 active not recruiting as of Aug 2023; primary completion date in Sep 2024. Aug 2019: Still listed as Phase 2 for SLE in UCB pipeline accessed online Aug 11, 2019. Oct 2018: Dapirolizumab pegol (DZP) did not meet the primary endpoint of demonstrating a dose response at 24 weeks on the British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) in a Phase II study, with a statistically insignificant difference (p=0.06) between the treatment and placebo arms. April 2018: UCB announced that top-line results from the Phase IIb study of dapirolizumab pegol (CD40L antibody) in systemic lupus erythematosus are expected in the fourth quarter of 2018. NCT02804763 Phase 2 recruiting as of Sep 2016. Partnered with Biogen Idec; in UCB pipeline as of April 2015; Biogen announced that they expect Phase I data for CDP7657 for SLE in the second half of 2014. Data published in Lupus in 2015: First-in-human trial of the safety, pharmacokinetics and immunogenicity of a PEGylated anti-CD40L antibody fragment (CDP7657) in healthy individuals and patients with systemic lupus erythematosus. |
| Full address of company | Brussels, Belgium Europe Belgium https://www.ucb.com/ |
None
| Anticipated events | None |
| Factor(s) contributing to discontinuation | None |