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(Sharecast News) - AstraZeneca announced on Thursday that the phase 3 'TULIP 2' trial for 'anifrolumab' - a potential new medicine for the treatment of systemic lupus erythematosus (SLE) - met its primary endpoint, achieving a statistically-significant and clinically-meaningful reduction in disease activity compared to placebo, with both arms receiving standard of care.
The FTSE 100 pharmaceuticals giant said the reduction was measured using the 'British Isles Lupus Assessment Group-based Composite Lupus Assessment' (BICLA) at week 52.
It explained that the BICLA required improvement in all organs with disease activity at baseline with no new flares, and added that the safety profile of anifrolumab was consistent with previous trials.
TULIP 2 was the second phase 3 trial designed to assess the safety and efficacy of anifrolumab as a treatment for adults with moderate-to-severe SLE.
The positive BICLA response in TULIP 2 was said to be consistent with a pre-specified analysis of the previous phase 3 TULIP 1 trial, which did not meet its primary endpoint of SLE Responder Index 4.
"Systemic lupus erythematosus is a debilitating autoimmune disease, but only one new treatment has been approved in the last 60 years," said Mene Pangalos, AstraZeneca's executive vice-president of biopharmaceuticals research and development.
"These are important results and we will now review the full data set and explore pathways to bring this potential new treatment to patients."
Professor Eric Morand of Australia's Monash University, principal investigator on the TULIP 2 trial, added that there was a clinical need for new medicines for the "complex and difficult-to-treat" disease.
"These exciting results from the TULIP 2 trial demonstrate that, by targeting the type I interferon receptor, anifrolumab reduced disease activity in patients with systemic lupus erythematosus."
AstraZeneca said data from TULIP 1 and TULIP 2 would be submitted for presentation at an upcoming medical meeting.
19 Feb 2024 08:36
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