Amicus Therapeutics Announces Positive Phase 3 Data From Fabry Monotherapy Study 012

August 20, 2014 10:05 AM

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CRANBURY, N.J., Aug. 20, 2014 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq:FOLD), a biopharmaceutical company at the forefront of therapies for rare and orphan diseases, today announced positive 18-month data from its second Phase 3 study (Study 012) of the oral small molecule chaperone migalastat HCl ("migalastat") in Fabry patients with amenable mutations. Detailed results of this second Phase 3 monotherapy study are available in a slide presentation that will be shared by the Amicus management team on a conference call today at 8:00 a.m. ET. Please visit http://ir.amicustherapeutics.com/events.cfm.

Study 012 compared oral migalastat to standard-of-care enzyme replacement therapies (ERTs) for Fabry disease (Fabrazyme(R) and Replagal(R)). The co-primary outcome measures were the mean annualized changes in estimated glomerular filtration rate (eGFR) and measured (iohexol) GFR (mGFR) assessed by d...

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