{"id":13775,"date":"2024-11-20T15:12:16","date_gmt":"2024-11-20T07:12:16","guid":{"rendered":"https:\/\/flcube.com\/?p=13775"},"modified":"2024-11-20T15:12:19","modified_gmt":"2024-11-20T07:12:19","slug":"ucb-and-biogens-dapirolizumab-pegol-shows-promise-in-phase-iii-sle-study","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=13775","title":{"rendered":"UCB and Biogen’s Dapirolizumab Pegol Shows Promise in Phase III SLE Study"},"content":{"rendered":"\n

Partners UCB (FRA: UNC) and Biogen Inc. (NASDAQ: BIIB<\/a>) have announced positive results from a Phase III study of their co-developed drug candidate, dapirolizumab pegol (DZP), a novel Fc-free anti-CD40L agent, when combined with the standard-of-care (SOC) in patients with moderate-to-severe systemic lupus erythematosus (SLE). The findings, which indicate a significant reduction in disease activity, were presented at ACR Convergence 2024 in Washington, DC.<\/p>\n\n\n\n

Study Design and Primary Endpoint<\/strong>
In the study, dapirolizumab pegol (DZP) was administered intravenously every four weeks. The primary endpoint, measuring the 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, showed that patients receiving DZP plus SOC had a statistically significant 14.6% higher response rate (49.5%) compared to those receiving SOC alone (34.6%). This higher BICLA response rate indicates a treatment response across all affected organs at baseline and is associated with meaningful clinical benefit.<\/p>\n\n\n\n

Secondary Endpoint and Statistical Significance<\/strong>
Regarding the first secondary endpoint of BICLA response at Week 24, patients receiving DZP plus SOC exhibited a 7.9% higher response rate (46.6%) than those on SOC alone (38.3%). However, this difference did not reach statistical significance.<\/p>\n\n\n\n

Dapirolizumab Pegol’s Mechanism of Action<\/strong>
Dapirolizumab pegol is a novel investigational humanized Fc-free polyethylene glycol (PEG)-conjugated antigen-binding (Fab\u2019) fragment. It works by inhibiting CD40L signaling, which has been shown to reduce B cell activation and autoantibody production, mitigate type 1 interferon (IFN) secretion, and attenuate T cell and antigen-presenting cell (APC) activation.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

Partners UCB (FRA: UNC) and Biogen Inc. 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