AstraZeneca’s Lupus treatment misses mark in trial

AstraZeneca’s  anifrolumab has failed to meet the primary objective in a late-stage clinical trial in moderate-to-severe systemic lupus erythematosus (SLE).

The news is a disappointment for AstraZeneca, but not a surprising one, as numerous other companies have had failures in the field.

TULIP 1, was a randomised, double-blinded, 52-week placebo-controlled trial, assessing the safety and efficacy of anifrolumab, administered as an intravenous injection, as a potential treatment for adult patients with SLE.

The aim of the study was to assess the effect of the drug in minimising disease activity, however the candidate failed to achieve a statistically significant reduction in disease activity in these patients.

The drug had hit the mark in earlier clinical trials and even gaining a fast-track status from the FDA in 2015.

The company has previously predicted the drug could become a $1bn product, but these hopes now look dashed, even if AZ hasn't yet formally abandoned the drug.  AstraZeneca has another trial lined up for the drug, TULIP 2, with data set to be available later this year. This differs only slightly from TULIP 1, comparing only the higher 300mg dose from the first trial against placebo over the same period.

Sean Bohen, executive vice president, Global Medicines Development and chief medical officer, said: “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.”

The candidate in question operates a differently to other lupus treatments, including already approved Benlysta, GlaxoSmithKline’s subcutaneous formulation of its market-leading product.

That was the first new product to treat Lupus in sixty years, and it’s still the only targeted treatment currently approved in the US for people with the disease, which affects 5 million people globally.

However, anifrolumab targets a protein that is involved in inflammation, known as interferon, and blocks all activity in this pathway, unlike Benlysta which blocks B-lymphocyte stimulator activity, which is associated with the production of antibodies that target the body’s own tissues.

Other companies with an interest in meeting the unmet need in lupus include Johnson & Johnson. Its blockbuster Stelara produced encouraging phase II results in the disease last November, while Gilead is working with Verily on an early stage research project to better understand the disease.