Clinical research jobs providers GlaxoSmithKline (GSK) and Amicus Therapeutics have announced the beginning of a phase III clinical trial of Amigal, a collaboratively developed Fabry disease treatment.
Study 012 aims to compare the safety and efficacy of Amigal to enzyme replacement therapy, with the first patient commencing dosing as part of the development.
The randomised, open-label, 18-month trial will include approximately 50 sufferers of the rare inherited lysosomal storage disorder across a number of international sites, with the results aiming to support regulatory submissions for the treatment.
Study 012 is the second of two phase III trials being carried out involving Amigal, which is said to provide benefits to renal function in terms of glomerular filtration rate.
Dr Philippe Monteyne, head of development and chief medical officer for GSK's rare diseases unit, said: "We believe Amigal has the potential to provide an important treatment option in Fabry disease."
GSK recently announced that it will expand its relationship with Anacor Pharmaceuticals in order to cover a wider range of diseases.