AZN : TULIP 1 Phase III Trial For Anifrolumab Fails To Meet Primary Endpoint

(RTTNews) - AstraZeneca (AZN.L, AZN) and MedImmune, its global biologics research and development arm, announced results from the TULIP 1 Phase III trial for anifrolumab in adult patients with moderate-to-severe systemic lupus erythematosus or SLE. 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 or SRI4 at 12 months.

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. A full evaluation of the data will be conducted when TULIP 2 data are available later this year. TULIP 1 data will be presented at a future medical meeting.