AstraZeneca’s experimental drug anifrolumab has failed to hit targets in a late stage trial in patients with lupus.
The Phase III TULIP 1 trial, which involved adults with moderate-to-severe systemic lupus erythematosus (SLE), did not the primary endpoint of a statistically-significant reduction in disease activity at 12 months.
Anifrolumab (formerly MEDI-546) 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.
Type I interferons are cytokines involved in the inflammatory pathways, and 60% - 80% of adult lupus patients have an increased type I interferon gene signature, which has been shown to correlate with disease activity, according to the firm.
“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,” said Sean Bohen, executive vice president, Global Medicines Development and Chief Medical Officer at AZ.
A full evaluation of the data will be conducted when TULIP 2 data are available later this year, the firm said, also adding that TULIP 1 data – the other late-stage trial in the programme - will be presented at a future medical meeting.