AstraZeneca, along with its global biologics research and development arm MedImmune, has reported the 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 has failed to 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, said AstraZeneca.
Tulip 1 was a randomised, double-blinded and 52-week placebo-controlled and multi-centre trial, which evaluated the safety and efficacy of anifrolumab as a treatment for adult patients with moderate-to-severe SLE.
AstraZeneca noted that the full assessment of the data will be carried out when Tulip 2 data is completely available later this year.
Anifrolumab, earlier known as MEDI-546, is a fully human monoclonal antibody and potential new medicine, which binds to subunit 1 of the type I interferon receptor, enabling to block the activity of all type I interferons such as IFN-α, IFN-β and IFN-ω.
The pivotal Tulip (treatment of uncontrolled lupus via the interferon pathway) program is comprised of two phase III clinical trials, Tulip 1and Tulip 2.
Both studies are designed to assess the efficacy and safety of anifrolumab against placebo in patients with moderately-to-severely active autoantibody-positive SLE who are securing standard of care treatment.
In Tulip 1 trial, the company randomized 460 eligible patients (1:2:2) to secure a fixed-dose intravenous infusion of 150mg anifrolumab, 300mg anifrolumab, or placebo every four weeks.
In Tulip 2 trial, the firm randomized 373 eligible patients (1:1) to secure a fixed-dose intravenous infusion of 300mg anifrolumab or placebo every four weeks.
AstraZeneca global medicines development executive vice president and chief medical officer Sean Bohen said: “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.”