AstraZeneca has announced positive results from its Phase III TULIP 2 trial, evaluating anifrolumab in moderate to severe systemic lupus erythematosus (SLE).
The drug demonstrated superiority across multiple efficacy endpoints versus placebo, with both arms receiving standard of care. The drug also achieved a statistically significant and clinically meaningful reduction in disease activity at week 52, with 47.8% of patients responding compared with 31.5% of patients on placebo, as well as statistically significant differences in multiple secondary endpoints.
The fully human monoclonal antibody works by binding 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.
Only one drug has been approved in the US for the indication in the lat 60 years, GlaxoSmithKline’s Benlysta (belimumab), which was also the first-ever biologic treatment for the disease.
Mene Pangalos, executive vice president, BioPharmaceuticals R&D said that this is the reason the company is “so excited to see the positive TULIP 2 results.”
He continued, “There is now a strong body of evidence demonstrating the benefit of anifrolumab, and we look forward to bringing this potential new medicine to patients with systemic lupus erythematosus as soon as possible.”
The data, published in The Lancet Rheumatology as well as being announced at the American College of Rheumatology (ACR) Annual Meeting 2019, also showed safety and tolerability findings consistent with the known profile of anifrolumab.
Systemic lupus erythematosus 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 can cause a range of symptoms including pain, rashes, fatigue, swelling in joints, and fevers.