29th Aug 2019 08:06
(Alliance News) - AstraZeneca PLC on Thursday said its phase 3 Tulip 2 trial of potential new lupus drug anifrolumab met its primary endpoint.
The trial assessed anifrolumab as a treatment for adults who have moderate to severe systemic lupus erythematosus and found "a statistically-significant and clinically-meaningful reduction in disease activity versus placebo".
The British Isles Lupus Assessment Group based Composite Lupus Assessment was used to measure disease reduction at 52 weeks. This assessment necessitates "improvement in all organs with disease activity at baseline with no new flares".
Tulip 2 is the second of Astra's phase 3 trials assessing anifrolumab's safety and efficacy and was consistent with Tulip 1 analysis, although Tulip 1 did not meet its primary endpoint of SLE Responder Index 4 , a different assessment.
Mene Pangalos, executive vice president of biopharmaceuticals research & development at AstraZeneca, said: "Systemic lupus erythematosus is a debilitating autoimmune disease, but only one new treatment has been approved in the last 60 years. These are important results, and we will now review the full data set and explore pathways to bring this potential new treatment to patients."
AstraZeneca shares were up 1.0% at the London open Thursday at 7,335.00 pence.
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