BioCentury
ARTICLE | Clinical News

Amicus, GSK Fabry's compound misses in Phase III trial

December 20, 2012 1:32 AM UTC

Amicus Therapeutics Inc. (NASDAQ:FOLD) and partner GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) said late Wednesday that Amigal migalastat missed the primary endpoint in the Phase III FACETS (Study 011) trial to treat Fabry's disease. Amicus was up $0.11 to $5.77 on Wednesday. In early after hours trading, the stock fell $2.92 (51%) to $2.85.

Specifically, 150 mg oral Amigal given every other day did not improve the proportion of patients with a 50% or greater reduction in kidney interstitial capillary globotriaosylceramide (GL-3) levels as measured in kidney biopsies from baseline at six months vs. placebo (41% vs. 28%, p=0.3). The trial enrolled 67 patients who had genetic mutations amenable to chaperone monotherapy in a cell-based assay. ...