Positive Ph III data for Amicus' migalastat as Fabry monotherapy
US biopharma company Amicus Therapeutics (Nasdaq: FOLD) has revealed positive 18-month data from its second Phase III study (Study 012) of the oral small molecule chaperone migalastat in Fabry patients with amenable mutations.
The company’s share rose over 20% to $5.50 in after-hours trading following the announcement on Wednesday, which adds to the positive findings of Study 011 released earlier this year.
Study 012 compared oral migalastat to standard-of-care enzyme replacement therapies (ERTs) for Fabry disease (Fabrazyme from Sanofi and Replagal from Shire). The co-primary outcome measures were the mean annualized changes in estimated glomerular filtration rate (eGFR) and measured (iohexol) GFR (mGFR) assessed by descriptive comparisons of migalastat and ERT over 18 months.
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