UCB and Biogen Announce Topline Results from a Phase 2b Study of Dapirolizumab Pegol in Systemic Lupus Erythematosus
Brussels, Belgium and Cambridge, MA – 23 October 2018, 7:00 AM CEST – Today UCB (Euronext Brussels: UCB) and Biogen Inc. (Nasdaq: BIIB) announced top-line results from a Phase 2b study evaluating the safety and efficacy of dapirolizumab pegol (DZP), an anti-CD40L pegylated Fab, in adults with moderately-to-severely active systemic lupus erythematosus (SLE) despite receiving standard-of-care treatment such as corticosteroids, anti-malarials and non-biological immunosuppressants.
The primary endpoint of the study to demonstrate a dose response at 24 weeks on the British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) was not met (p=0.06). The study did demonstrate consistent and potentially meaningful improvements for the majority of clinical endpoints in patients treated with DZP compared with placebo. In addition, biomarker data demonstrated evidence of proof of biology. DZP was well tolerated and demonstrated an acceptable safety profile.
Biogen and UCB continue to further evaluate these data while assessing potential next steps. The companies expect to present this data at a future scientific forum.
About Dapirolizumab Pegol
Dapirolizumab pegol is an investigational anti-CD40L pegylated Fab being developed in systemic lupus erythematosus (SLE) jointly by UCB and Biogen. Through interactions with its receptor, CD40, CD40L plays an important role in regulating interactions between T cells and other immune cells, notably B cells and antigen presenting cells, and thus affects several
important functional events thought to be involved in autoimmune disease.