Mid-stage Clinical Trial of DZP Misses Primary Endpoint
A mid-stage clinical trial to evaluate the safety and efficacy of the biologic dapirolizumab pegol (DZP) in adults with moderately-to-severely active lupus erythematosus did not meet its primary endpoint. Investigators had hoped to demonstrate a statistically significant dose-response at 24 weeks using a widely accepted disease activity assessment tool.
However, while the phase 2 trial of DZP did not reach its primary endpoint, it did show consistent and potentially meaningful improvements for the majority of other clinical endpoints in patients that were treated with DZP compared with placebo. The results were reported Tuesday in a media release issued by UCB and Biogen Inc., which conducted the study.
UCB and Biogen, Inc. are developing DZP as a potential therapy for lupus. DZP is an antibody fragment that binds to a protein that is activated on the CD40 ligand (CD40L), which is described in the scientific literature as one of the key players in regulating T cell, B cell and antigen-presenting cell activity.
The companies also reported that data for lupus-related biomarkers showed that DZP provided some evidence of biology. For more information, read the media release published on the UCB website.