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AstraZeneca PLC (NASDAQ:AZN) announced Wednesday that its Phase III TULIP-SC trial evaluating subcutaneous administration of Saphnelo (anifrolumab) in patients with systemic lupus erythematosus (SLE) met its primary endpoint based on a pre-specified interim analysis.
According to the press release statement, the interim results showed that Saphnelo administered subcutaneously demonstrated a statistically significant and clinically meaningful reduction in disease activity compared to placebo in patients with moderately to severely active, autoantibody-positive SLE. The safety profile observed was consistent with the known clinical profile of Saphnelo when administered as an intravenous infusion.
The TULIP-SC trial enrolled 367 participants who were randomized to receive either Saphnelo or placebo, in addition to standard therapy, which included oral corticosteroids, antimalarials, and/or immunosuppressants. Disease activity reduction was measured using the British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) at week 52. A planned interim analysis was conducted when the first 220 participants reached week 52.
Saphnelo is a monoclonal antibody that targets the type I interferon receptor. The intravenous formulation of Saphnelo is approved for the treatment of moderate to severe SLE in more than 70 countries, including the United States, European Union, and Japan. Regulatory reviews for the subcutaneous formulation are ongoing.
AstraZeneca acquired global rights to Saphnelo through an exclusive license and collaboration agreement with Medarex, Inc. in 2004. Under the agreement, AstraZeneca will pay Bristol-Myers Squibb a low to mid-teens royalty for sales, dependent on geography.
The interim results from the TULIP-SC trial are under regulatory review and are scheduled to be presented at the American College of Rheumatology Convergence 2025 annual meeting, which will take place from October 24 to 29, 2025.
This information is based on a press release statement filed with the Securities and Exchange Commission.
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