Biogen/UCB Partnered Autoimmune Disease Candidate Hits Primary Goal In Late-Stage Study, Sets Stage Another Pivotal Trial

Tuesday, UCB SA UCBJY UCBJF and Biogen Inc. BIIB released topline results from the Phase 3 PHOENYCS GO study of dapirolizumab pegol for moderate-to-severe systemic lupus erythematosus (SLE).

SLE is a chronic autoimmune disease that can affect many organs in the body. It occurs when the body’s immune system attacks healthy tissue, causing inflammation and sometimes permanent tissue damage.

SLE can present itself in several ways, including rash, arthritis, anemia, thrombocytopenia, serositis, nephritis, seizures or psychosis.

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Dapirolizumab pegol, in addition to standard-of-care (SOC) treatment, met the primary endpoint to demonstrate greater improvement of moderate-to-severe disease activity after 48 weeks versus placebo in addition to SOC. The study enrolled 321 patients.

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

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.

UCB and Biogen are initiating a second Phase 3 trial of dapirolizumab pegol in 2024, PHOENYCS FLY.

Participants from the PHOENYCS GO study will continue to be followed in a long-term open-label study.

Detailed results from the PHOENYCS GO study will be presented at an upcoming medical congress.

Price Action: At last check Tuesday, BIIB stock was up 1.66% at $199.06 during the premarket session.

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