UCB and Biogen Announce Positive Phase 3 Results for Dapirolizumab Pegol in Systemic Lupus Erythematosus, Plan Second Phase 3 Trial

Positive Phase 3 Results:
UCB and Biogen have announced positive topline results from the Phase 3 PHOENYCS GO study evaluating dapirolizumab pegol in patients with moderate-to-severe systemic lupus erythematosus (SLE).

Primary Endpoint Met:
Dapirolizumab pegol, in addition to standard-of-care treatment, met the primary endpoint by demonstrating greater improvement of moderate-to-severe disease activity as assessed by the British Isles Lupus Assessment Group (BILAG)-based Composite Lupus Assessment (BICLA) after 48 weeks.

Secondary Endpoints:
Clinical improvements were observed among key secondary endpoints measuring disease activity and flares.

Safety Profile:
The safety profile of dapirolizumab pegol was generally consistent with previous studies and with that expected in study participants with systemic lupus erythematosus receiving an immunomodulator.

Second Phase 3 Trial:
Encouraged by the positive results, UCB and Biogen are initiating a second Phase 3 trial, PHOENYCS FLY, in 2024.

Long-term Open-Label Study:
Participants from the PHOENYCS GO study will continue to be followed in a long-term open-label study.

Market Potential:
If approved, dapirolizumab pegol could unlock a $1 billion to $2 billion opportunity for the companies, with Biogen and UCB planning to co-promote the drug and split sales evenly.