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Amicus Therapeutics Presents Positive Data Update From Phase 2 Extension Study of Amigal(TM) for Fabry Disease
Date:2/11/2010

ion rate (eGFR) and proteinuria.  Preliminary data indicate that eGFR has remained stable out to 2-3 years for all subjects continuing in the extension study and the average annual rate of change in eGFR in subjects identified as responders to migalastat HCl, excluding hyperfiltrators, was +2.0 mL/min/1.73m2.  Additionally, trends of reduced proteinuria continued to be observed in subjects identified as responders to migalastat HCl.

Derralynn Hughes, MA, DPhil, FRCPath, Senior Lecturer in Haematology Department Academic Haematology, Royal Free & University College Medical School, London, UK, stated, "The additional renal function data with migalastat from the ongoing extension study are encouraging.  The eGFR results were particularly of interest as the data at this point in the study compare favorably to the previously published eGFR literature in untreated and ERT-treated Fabry patients."

As previously announced, a Phase 3 study intended to support approval in the United States (Study 011) commenced in the second quarter of 2009 and treatment of the first patient began in the fourth quarter of 2009.  The Company expects to complete enrollment by the end of 2010 and to have preliminary results in mid-2011.  

In addition, the Company expects to commence a separate Phase 3 study (Study 012) before year end. Study 012 is intended to support approval in the European Union and will be an 18-month, randomized, open-label study comparing migalastat HCl to ERT in approximately 60 subjects. The primary outcome of efficacy will be renal function as measured by glomerular filtration rate (GFR).

John F. Crowley, Chairman and CEO of Amicus Therapeutics, added, "We are very pleased with the continued positive Amigal data and remain confident that our Phase 3 program will b
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SOURCE Amicus Therapeutics
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