AstraZeneca's anifrolumab trial fails to meet primary endpoint

31st Aug 2018 09:00

(Sharecast News) - AstraZeneca and its global biologics research and development arm MedImmune announced top-line results from the TULIP 1 Phase III trial for anifrolumab in adult patients with moderate-to-severe systemic lupus erythematosus (SLE) on Friday.The FTSE 100 pharmaceuticals giant said the trial did not meet the primary endpoint of a statistically-significant reduction in disease activity in patients with SLE as measured by the SLE Responder Index 4 (SRI4) at 12 months."SLE is a debilitating autoimmune disease with significant unmet need among patients who struggle to achieve meaningful disease control," said AstraZeneca's executive vice-president of global medicines development and chief medical officer Sean Bohen."The result of this trial is disappointing for patients and the lupus community."The company said the pivotal Phase III TULIP 1 trial was a randomised, double-blinded, 52-week placebo-controlled, multi-centre trial assessing the safety and efficacy of anifrolumab as a treatment for adult patients with moderate-to-severe SLE.It said a full evaluation of the data would be conducted when TULIP 2 data was available later this year, with TULIP 1 data to be presented at a future medical meeting.