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AstraZeneca flags positive trial data for Saphnelo as SLE treatment

ALN

AstraZeneca PLC on Tuesday said a Saphnelo self-administration Thlip-SC trial demonstrated statistically significant and clinically meaningful reduction in systemic lupus erythematosus disease activity.

The Cambridge, England-based pharmaceuticals firm said the Tulip-SC trial showed 56.2% of patients who received Saphnelo achieved a reduction in disease activity at week 52 versus 37.1% receiving placebo, consistent with results from previous trials.

The safety profile observed in the trial was consistent with the known clinical profile of Saphnelo administered as an intravenous infusion.

The full results confirmed the findings from the interim analysis, which was ‘statistically significant,’ AstraZeneca said.

Sharon Barr, executive vice president, BioPharmaceuticals R&D, AstraZeneca, said: ‘These results reinforce Saphnelo’s unique approach of targeting the type 1 interferon receptor to reduce disease activity, with the added convenience of subcutaneous self-administration. The Tulip-SC findings build on the compelling body of evidence for Saphnelo, which has helped patients achieve remission and significantly reduce reliance on oral corticosteroids  further reinforcing our ambition to transform lupus care.’

Saphnelo IV infusion is approved for the treatment of moderate to severe SLE in more than 70 countries worldwide including the US, EU and Japan, with regulatory reviews ongoing in other countries including China.

Shares in AstraZeneca rose 1.5% to 13,578.26 pence each in London on Tuesday morning.

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