Merck Serono commences enrolment for Kuvan trial

Merck Serono has commenced enrolment for a new phase IIIb clinical study of Kuvan, its treatment for Phenylketonuria (PKU).

The first patients have been recruited for Spark, a trial that will evaluate the safety, efficacy and population pharmacokinetics of the treatment among patients younger than four years of age.

Kuvan has been approved as a PKU therapy for the disease among those aged four years and above since December 2008.

It was the first treatment option made available for the rare metabolic disorder, which can lead to toxic levels of amino acids accumulating in the brain and blood and is usually associated with strict lifelong dietary restrictions.

Dr Bernhard Kirschbaum, executive vice-president for global research and development at Merck Serono, said: "Beyond the implementation of Spark as a follow-up measure agreed with the European Medicines Agency, we want to make Kuvan available for patients who could benefit from it."

This comes after the company completed enrolment of a new clinical trial for the drug cilengitide last month, which will assess its efficacy against glioblastoma.