The drug candidate demonstrated significant clinical improvement in disease activity in patients with moderate-to-severe systemic lupus erythematosus (SLE).
The results were shared at the American College of Rheumatology’s annual meeting. In the 321-subject trial, DZP was administered intravenously every four weeks.
On the primary endpoint measuring improvement of moderate-to-severe disease activity after 48 weeks, study participants receiving DZP plus standard care had a statistically significant 14.6% higher response rate (49.5%) than those receiving SOC alone (34.6%).
On the first secondary endpoint of disease activity response at Week 24, study participants receiving DZP plus SOC had a 7.9% higher response rate (46.6%) than those receiving SOC alone (38.3%). However, the difference did not reach statistical significance.
A greater response was observed across multiple clinical endpoints among participants treated with DZP, including 50% less severe disease flares than participants on standard of care alone.
Participants from the PHOENYCS GO study will continue to be followed in a long-term open-label study.
In 2024, UCB and Biogen will initiate a second Phase 3 trial of dapirolizumab pegol, PHOENYCS FLY.
From a stock perspective, William Blair writes that dapirolizumab isn’t significantly impacting Biogen’s valuation, as investors remain focused on Leqembi’s commercial rollout, which is still a work in progress.
The success of Biogen’s late-stage development programs is crucial for future growth, complementing opportunities from Leqembi, Skyclarys, and potentially zuranolone, especially as its multiple sclerosis business continues to feel pressure from generic competition.
Price Action: BIIB stock is down 0.72% at $154.31 at last check Wednesday.
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