Study 011 is a randomized study with a 6-month, double-blind, placebo-controlled primary treatment period and a 6-month, open-label follow-up period in which all subjects receive treatment with migalastat HCl. The primary endpoint in Study 011 is a change in interstitial capillary GL-3 as measured in kidney biopsy at 6 months versus baseline. The 6-month primary treatment period in Study 011 was completed in the second quarter 2012 and the 6-month follow-up period is expected to complete in the fourth quarter 2012. Amicus and GSK expect to unblind and analyze data from the primary 6-month treatment arm during the fourth quarter 2012. Both companies remain blinded to all results at this time.John F. Crowley, Chairman and Chief Executive Officer of Amicus stated, "Screening results from Study 011 suggest that migalastat HCl monotherapy may address a substantial portion of the Fabry population on the basis of genotype. In addition, these screening results may provide the Fabry patient and physician community with valuable information on a wide variety of different mutations, including newly discovered mutations."
Amicus Therapeutics Presents Updated Patient Screening Profiles From Phase 3 Fabry Study
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