Drug Development

Did Merck KGaA’s aging atacicept just fail a PhIIb lupus trial? Well, yes, but…

Luciano Rossetti, Merck KGaA

Luciano Rossetti, Merck KGaA

Merck KGaA says that atacicept, one of its top, long-running drug prospects in the pipeline, failed a Phase IIb trial for lupus. That failure follows a 2009 flop for multiple sclerosis, but Merck KGaA is nothing if not persistently sunny in the face of all setbacks.

The German Merck, not to be confused with the U.S. rival by the same name, says the drug missed on the primary endpoint: the proportion of patients achieving a clinical response as defined by a composite SLE Responder Index (SRI)-4 at week 24.

But, it quickly followed up with a roster of upbeat results for a pre-specified sensitivity analysis as well as a significant reduction in disease flares when compared to a placebo arm.

Merck KGaA has significantly revised its pipeline work in the last two years, part of an ongoing reorganization that followed its decision to shut down the Serono ops in Geneva back in 2012.

It’s been well over a decade since Merck KGaA has had a blockbuster hit from R&D. Big flops in cancer vaccines and MS followed. But it partnered with Pfizer on its checkpoint drug, looking for a late entry against the U.S. Merck, Bristol-Myers Squibb and Roche. And it’s taking yet another stab at getting an approval for cladribine, its once dead-and-buried drug for MS. The drug is under review at the EMA again.

Merck KGaA can also be slow in spelling out its setbacks. It took 5 years for the company to detail the 2009 MS flop.

R&D chief Luciano Rossetti, based in Darmstadt, had this to say today:

“Building on the results of the APRIL SLE study, the results of ADDRESS II show that atacicept has the potential to become an important option for patients with lupus. We are particularly encouraged by the results in patients with high disease activity – which was approximately 50% of the patients in the ADDRESS II study. We are looking forward to discussions with the regulatory authorities.”


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