In latest setback, AstraZeneca’s high hopes for its lupus drug anifrolumab crushed by a PhIII failure

The last of the late-stage autoimmune drugs still left at AstraZeneca just went down to a stinging defeat in Phase III.

The pharma giant didn’t waste any time with its statement. Their drug anifrolumab — which they once held high hope of success for — failed the primary endpoint for lupus: significantly reducing disease activity for patients with systemic lupus erythematosus.

This is the first of two Phase III studies for this antibody, which targets type I interferons including IFN-α, IFN-β and IFN-ω. But with the first big, 52-week trial a flop, the whole program — including two other mid-stage trials — have just come under a very dark cloud.

AstraZeneca’s shares were down 2% in early trading Friday.

Bing Yao

You’ll find anifrolumab among a handful of therapies still left in what AstraZeneca designates as its “other” drug category. These drugs don’t fall into one of its three key R&D focuses — including a few surviving neuroscience efforts. The top crew at AstraZeneca decided to hold on to the autoimmune antibody early this year when they spun out a group of related therapies into a new company dubbed Viela — now helmed by their former autoimmune research chief Bing Yao.

Pascal Soriot

The setback here underscores AstraZeneca’s dilemma. It’s been successful in making some landmark advances in oncology, but the rest of the pipeline has been a sore disappointment — offering little help to CEO Pascal Soriot as the company tries to steer its way back to growth after years of declining revenue and loss of patent protection for its mainstay drugs. And it comes just days after the pharma giant was forced to concede another delay in completing its sprawling new HQ building in Cambridge, as costs continue to climb and the finish date now stretches out to 2020.

Yao and others highlighted their optimism for anifrolumab after their Phase II results came out a few years ago.

Richard Furie

The principal investigator, Richard Furie, had this to say at the time: 

The lupus community has been disappointed too often with clinical trial results. We have been eagerly awaiting clinical data of this magnitude for many years. These results provide very compelling evidence that blocking the type 1 interferon system with an inhibitor of the type I interferon receptor is a promising strategy for the treatment of SLE and support the progression of anifrolumab into Phase III.

But once again, Phase II enthusiasm has met a bitter outcome in Phase III.

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