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Amicus Therapeutics Commences Phase 3 Trial Evaluating Amigal(TM) for the Treatment of Fabry Disease
Date:6/22/2009

arting and look forward to continued involvement with this novel approach for the treatment of Fabry disease."

Amigal U.S. Registration Phase 3 Trial Design

The Phase 3 trial will evaluate the efficacy, safety and pharmacodynamics of Amigal in males and females with Fabry disease. This trial will consist of a six-month double-blind, randomized, placebo-controlled treatment stage and will enroll approximately 60 subjects who are naive to enzyme replacement therapy (ERT) or who have not received ERT for at least six months prior to the start of treatment with Amigal. The Amigal treatment arm dose and regimen will be 150 mg every other day.

The primary endpoint will be the change in the amount of kidney interstitial capillary GL-3 as measured in kidney biopsies using histology. Secondary endpoints will include safety and tolerability, kidney GL-3 as measured in urine, and an assessment of renal function (including glomerular filtration rate (GFR) and 24-hour urine protein).

Additionally, the FDA and Amicus reached agreement on an improved methodology for the histological evaluation of GL-3 in the kidney biopsies. An analysis of the Phase 2 and Phase 2 extension study biopsies using the improved methodology demonstrated that all of the evaluable baseline samples had detectable interstitial capillary GL-3 and that reductions were observed in 8 of the 9 responders.

According to Laura Barisoni, MD, Assistant Professor in Pathology and Medicine, Director, Nephropathology Service, Department of Pathology, New York University School of Medicine, "The Phase 2 data using the improved methodology for histological evaluation of GL-3 in kidney biopsies were very encouraging and provide added confidence in the planned Phase 3 study."

It is expected that approximately 30 clinical sites worldwide will participate in this tria
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SOURCE Amicus Therapeutics
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