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Amicus Therapeutics Provides Positive Data Update from Phase 2 Long-Term Extension Study of Amigal™ for Fabry Disease
Date:2/16/2011

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 +1.6 mL/min/1.73m2.  Additionally, reduced 24-hour urine protein continues to be observed in multiple subjects identified as responders to migalastat HCl, with a mean 21% and median 34% reduction from baseline in this group of subjects.

Co-administration with ERT in Fabry Disease and Pompe DiseaseAmicus previously reported promising preclinical data demonstrating that the co-administration of a pharmacological chaperone with ERT has the potential to address key limitations of ERT. The addition of a pharmacological chaperone has been shown to prevent the loss of activity of ERT in the circulation, increase tissue uptake, and increase substrate reduction in multiple disease-relevant tissues. Preclinical proof of concept has been established for Fabry disease and Pompe disease.

The Company will present a review of new and historical data from preclinical studies of migalastat HCl co-administered with ERT in an animal model of Fabry disease.  Amicus and its partner GlaxoSmithKline PLC (GSK) are sponsoring an ongoing Phase 2 study evaluating the co-administration of migalastat HCl with ERT for Fabry disease.  Results from this study are expected in the second half of 2011.

In addition, Amicus will present pharmacokinetics and muscle distribution data from a Phase 1 study of AT2220 that support the planned Phase 2 clinical study of AT2220 co-administered with ERT in Pompe patients.  The Company expects to initiate this study in the first half of 2011 and to report preliminary results in the second half of 2011. The Company intends to seek U.S. FDA approval to lift the current hold on the AT2220 program as part of its development plan.

Diseases of NeurodegenerationAmicus is investigating the potential use of pharmacological chaperones f
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SOURCE Amicus Therapeutics
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