AstraZeneca has announced that its potential new systemic lupus erythematosus (SLE) medicine, anifrolumab, has met its primary endpoint, achieving a statistically-significant and clinically-meaningful reduction in disease activity.
The reduction was measured using the British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) at week 52, which requires improvement in all organs with disease activity at baseline with no new flares. The company also confirmed that the safety profile of the drug was consistent with previous trials.
The trial, TULIP 2, was the second Phase III trial designed to assess the safety and efficacy of anifrolumab as a treatment for adults with moderate-to-severe SLE, and the positive BICLA response in TULIP 2 was consistent with a pre-specified analysis of the previous Phase III TULIP 1 trial, which did not meet its primary endpoint.
The new drug is a fully human monoclonal antibody that binds to subunit 1 of the type I interferon receptor, blocking the activity of all type I interferons including IFN-alpha, IFN-beta and IFN-omega.
Professor Eric F. Morand, Monash University, Australia, and principal investigator on the TULIP 2 trial said: “As clinicians we need new medicines for this complex and difficult-to-treat disease. These exciting results from the TULIP 2 trial demonstrate that, by targeting the type I interferon receptor, anifrolumab reduced disease activity in patients with systemic lupus erythematosus.”
SLE is an autoimmune disease in which the immune system attacks healthy tissue in the body. It is a chronic and complex disease with a variety of clinical manifestations that can impact many organs and cause a range of symptoms including pain, rashes, fatigue, swelling in joints and fevers and is associated with a greater risk of death from causes such as infection and cardiovascular disease.
There has been only one new medicine approved for SLE in the last 60 years.