The TULIP 2 trial was the second Phase III trial that assessed the safety and efficacy of anifrolumab as a treatment for adults with moderate-to-severe SLE.
AstraZeneca is aiming to be the second company over the past 60 years to garner a win for a new treatment for patients with systemic lupus erythematosus (SLE).
This morning, the U.K.-based company announced that its Phase III TULIP 2 trial assessing anifrolumab for the treatment of SLE hit the mark. The experimental drug met its primary endpoint of achieving a statistically-significant and clinically-meaningful reduction in disease activity versus placebo. The reduction in disease activity was measured using the British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) after 52 weeks of use. The BICLA measurement requires improvement in all organs with disease activity at baseline with no new disease flares.
The TULIP 2 trial was the second Phase III trial that assessed the safety and efficacy of anifrolumab as a treatment for adults with moderate-to-severe SLE. AstraZeneca said the BICLA response in the latest trial was consistent with a pre-specified analysis of the previous Phase III TULIP 1 trial, which did not meet its primary endpoint of SLE Responder Index 4.
AstraZeneca’s anifrolumab 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. Between 60% and 80% of adults with SLE have an increased type I interferon gene signature, which has been shown to correlate with disease activity, the company said.
“Systemic lupus erythematosus is a debilitating autoimmune disease, but only one new treatment has been approved in the last 60 years. These are important results and we will now review the full data set and explore pathways to bring this potential new treatment to patients,” Mene Pangalos, head of biopharmaceutical R&D at AstraZeneca said in a statement.
Systemic lupus erythematosus, the most common form of lupus, is an autoimmune disorder that triggers inflammation in different tissues of the body. SLE causes the immune system attacks its own tissues and causes widespread inflammation and tissue damage in the affected areas, according to the U.S. Centers for Disease Control and Prevention. Approximately five million people suffer from a form of SLE. About 90 percent of diagnosed patients are women. There has been only one new medicine approved for SLE in the last 60 years, GlaxoSmithKline’s Benlysta, which was approved by the FDA in 2016. Benlysta picked up another approval earlier this year for pediatric patients with lupus.
AstraZeneca and other companies have been racing to match GSK in providing new treatment options for SLE. Last year, Eli Lilly and Incyte Corporation picked up Fast Track designation from the FDA for their SLE drug, baricitinib. Lilly is currently studying two doses of baricitinib in Phase III SLE trials. Also last year, Nektar Therapeutics launched a Phase Ib study of its asset NKTR-358 in SLE. France-based Ablynx had a significant setback last year with a mid-stage failure of its SLE treatment, vobarilizumab.
Full data from both the TULIP 1 and TULIP 2 trials will be presented at a medical conference. In addition, the TULIP program includes a Phase III long-term extension trial in SLE and a Phase II trial in lupus nephritis, the company said.
