GlaxoSmithKline and Amicus initiate Fabry disease drug trial

GlaxoSmithKline and Amicus Therapeutics have announced the commencement of a new phase III clinical trial of Amigal, their collaboratively developed Fabry disease therapy.

The first patient has commenced dosing as part of Study 012, a global registration study that will compare the safety and efficacy of Amigal to enzyme replacement therapy.

A randomised, open-label, 18-month trial, Study 012 will enrol around 50 male and female sufferers of the rare inherited lysosomal storage disorder across 50 global sites, with data intended to support regulatory submissions for the drug.

It is the second of two phase III trials being conducted for Amigal, which is thought to provide benefits to renal function in terms of glomerular filtration rate.

Dr Philippe Monteyne, head of development and chief medical officer for GlaxoSmithKline's rare diseases unit, said: "We believe Amigal has the potential to provide an important treatment option in Fabry disease."

Earlier this month, it was announced that GlaxoSmithKline will be expanding its working relationship with Anacor Pharmaceuticals to cover a more diverse range of diseases.