Amicus Therapeutics announced initiation of its Phase 2 study of Amigal (migalastat hydrochloride) with enzyme replacement therapy (ERT) for the treatment of Fabry disease. This study is an open-label trial investigating drug-drug interactions between Amigal and Fabrazyme (agalsidase alpha) and Replagal (agalsidase beta) —both ERTs from Genzyme. The primary efficacy endpoint is the comparison of the ERT activity in plasma and safety and tolerance with and without co-administration of Amigal.

Amigal is designed to selectively bind to and stabilize the enzyme alpha-galactosidase A (a-Gal A), which facilitates proper trafficking of the enzyme to the lysosomes, where it is needed to break down GL-3. Fabry disease is a lysosomal storage disorder caused by inherited genetic mutations in the GLA gene.

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