UCB SA and Biogen Inc. have announced encouraging results from their Phase 3 PHOENYCS GO study, which evaluated the effectiveness of dapirolizumab pegol in treating moderate-to-severe systemic lupus erythematosus (SLE). SLE is a chronic autoimmune disease that affects various organs in the body, causing inflammation and potential tissue damage.
The study, which enrolled 321 participants, revealed that dapirolizumab pegol, when used alongside standard-of-care treatment, significantly improved disease activity after 48 weeks compared to placebo. This positive outcome met the primary endpoint of the study.
The researchers also observed clinical improvements in key secondary endpoints related to disease activity and flares. These findings suggest that dapirolizumab pegol could offer a new therapeutic option for patients with moderate-to-severe SLE.
The safety profile of dapirolizumab pegol in this study was consistent with previous findings and aligned with expectations for immunomodulators used to treat systemic lupus erythematosus.
Building on the success of PHOENYCS GO, UCB and Biogen are planning a second Phase 3 trial, PHOENYCS FLY, in 2024. Participants from the PHOENYCS GO study will continue to be monitored in a long-term open-label study. The detailed results from the PHOENYCS GO study will be presented at an upcoming medical congress.
The announcement of these positive results has been well-received by the market. At last check, Biogen’s stock (BIIB) was up 1.66% at $199.06 during the premarket session.
