Could phase 3 trial win save AZ’s troubled Lupus drug?
AstraZeneca has been on a hot streak of trial successes recently, with the latest win being in a late-stage study for a potential lupus drug that looked dead and buried after a major trial flop last year.
The company said that the phase 3 TULIP 2 trial for anifrolumab in systemic lupus erythematosus met its primary endpoint, offering hope that the drug could make it to market after all.
In the latest reuslts, anifrolumab showed a statistically significant and clinically meaningful reduction in disease activity versus placebo, with both arms receiving standard of care.
AZ has already announced results from its DAPA-HF trial this week, showing its SGLT2-class drug Farxiga (dapagliflozin) improves outcomes in patients with heart failure, regardless of whether they have type 2 diabetes.
The results could redefine how heart failure is treated, and the company also announced it has phase 3 data further supporting use of its Breztri Aerosphere in COPD where it hopes to take on UK pharma rival GlaxoSmithKline.
This is the second set of phase 3 results from anifrolumab, which flopped in the TULIP 1 trial results published a year ago this month.
AZ hoped that anifrolumab could become a blockbuster, competing against the only other SLE drug on the market, GlaxoSmithKline’s Benlysta (belimumab).
Details of the trials have yet to be published, but it’s likely that AZ will look at the data from all the anifrolumab studies and try to make the case to regulators that the totality of the evidence supports approval.
Mene Pangalos, executive vice president of BioPharmaceuticals R&D at AZ, 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.”
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.
Type I interferons are cytokines involved in the inflammatory pathways. 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.
SLE is an autoimmune disease in which the immune system attacks healthy tissue in the body.
Symptoms include pain, rashes, fatigue, swelling in joints and fevers and it is associated with a greater risk of death from causes such as infection and cardiovascular disease.
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