The 1st patient has been dosed in the P-III (IRIS) trial to evaluate anifrolumab vs PBO in 360 patients aged 18 to 70yrs. with LN. The objective of the study is to evaluate the efficacy & safety of anifrolumab when added to standard therapy in adults with active Class III or IV LN
The results from the P-II (TULIP-LN1) trial evaluate anifrolumab which failed to meet its 1EPs (69% vs 70%) & the higher dose showed clinically numeric improvements across multiple 2EPs & exploratory EPs
Saphnelo is a fully human mAb that binds to subunit 1 of the type I IFN receptor & inhibits its function. The therapy has been approved in the US, Japan, EU & Canada for SLE while regulatory reviews are underway in other countries globally
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