Merck KGaA begins phase II Atacicept study

German pharmaceutical firm Merck KGaA has begun its phase II/III trial testing of Atacicept on patients suffering from chronic autoimmune disease systemic lupus erythematosus (SLE).

Along with its development partner ZymoGenetics, the company will be looking into the possibility of using the drug as a treatment for SLE – which can be fatal.

Researchers will be analysing the effects of the drug – formerly known as TACI-Ig – and whether it is safe for SLE patients to use.

It follows a study by the same two companies in December 2007 which evaluated the effectiveness of the drug on those with lupus nephritis – a severe form of the disease.

The second phase of the trial will involve 500 patients with SLE taking either a placebo or Atacicept for a year.

Researchers will then analyse the proportion of patients – either placebo-controlled or taking the drug – that experience a new disease flare.

“Atacicept has the potential to alter the course of SLE, a complex and devastating disease,” said Anton Hoos, Merck head of global development.

“This study should provide us with a basis for assessing treatment outcomes with Atacicept.”

The cause of SLE is not yet known but it is believed to be influenced by factors such as inherited genes, viruses, ultraviolet light and even drugs.