Anifrolumab Trial Does Not Meet Primary Endpoint

AstraZeneca and 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).

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. The result of this trial is disappointing for patients and the lupus community," Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer, said.

The pivotal Phase III TULIP 1 trial was a randomized, double-blinded, 52-week placebo-controlled, multi-center 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.

Anifrolumab (formerly MEDI-546) is a fully human monoclonal antibody and potential new medicine that binds to subunit 1 of the type I interferon receptor, blocking the activity of all type I interferons including IFN-α, IFN-β and IFN-ω. Type I interferons are cytokines involved in the inflammatory pathways.2 60% - 80% of adult lupus patients have an increased type I interferon gene signature, which has been shown to correlate with disease activity.

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