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Amicus Therapeutics Initiates Phase 2 Clinical Trial Evaluating Amigal™ Co-administered with Enzyme Replacement Therapy
Date:2/9/2011

ore study entry.  Patients enrolled in this study need not have a genetic mutation responsive to Amigal as a monotherapy.  Each patient will receive ERT alone and then ERT after administration of a single oral dose of Amigal.  There will be two cohorts of nine patients treated with one of two Amigal dose levels.

The primary outcome measure will be a comparison of the ERT activity in plasma and safety and tolerance with and without coadministration of Amigal.  The effect of co-administration of ERT on the pharmacokinetics and safety of Amigal will also be evaluated.  A secondary outcome measure includes distribution of the ERT to skin.  Other outcome measures include evaluating the effect of co-administration of Amigal and ERT on GL-3 levels in skin and GL-3 excretion in urine.  Amicus expects results from this study to be available in the second half of 2011.

Approximately five clinical sites will participate in this trial in the United States and in Europe.

About Amigal

On October 29, 2010, Amicus announced a definitive agreement with GSK to develop and commercialize Amigal (migalastat HCl), currently in Phase 3, for the treatment of Fabry disease as a monotherapy. Under the terms of the agreement, GSK received an exclusive worldwide license to develop, manufacture and commercialize migalastat HCl. As part of the agreement, GSK and Amicus also intend to investigate Amigal as a potential treatment for Fabry disease when co-administered with ERT.  

The Phase 3 study (Study 011) of migalastat HCl is ongoing and patients are being enrolled at 36 investigational sites worldwide.  A majority of the planned 60 patients have been enrolled in the study. The Company expects to complete enrollment in the first half of 2011 and to report top line results from this study in the second half of 2011.

Amicus and GSK intend to commence an additional Phase 3 study (Study 012) in t
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SOURCE Amicus Therapeutics
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