Amicus Therapeutics Inc. (FOLD) Wednesday said its second Phase 3 trial or Study 012 of investigational product Migalastat in Fabry patients with amenable mutations, achieved both co-primary endpoints of comparability to Enzyme Replacement Therapy or ERT on both key measures of kidney function.
The Study enrolled 60 patients with Fabry disease with amenable mutations in a clinical trial assay who had been treated with ERT for a minimum of 12 months prior to study entry. The results showed that Migalastat was generally safe and well-tolerated.
John Crowley, CEO of Amicus said, "We believe that this multi-year study unequivocally demonstrates that a Fabry patient on ERT with an amenable mutation can switch safely and effectively from ERT to migalastat to treat their Fabry disease... These results clearly show that migalastat is comparable to ERT in slowing the progression of Fabry disease and continues to demonstrate a favorable safety profile"
For comments and feedback contact: editorial@rttnews.com
Business News