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ARTICLE | Clinical News

Corlux mifepristone: Additional Phase III data

June 13, 2011 7:00 AM UTC

Additional data from the subgroup of glucose intolerant patients with endogenous Cushing's syndrome (n=29) in the open-label, U.S. Phase III SEISMIC trial in 50 patients showed that once-daily oral Corlux significantly reduced mean HbA1c from 7.4% at baseline to 6.3% at week 24 (p<0.001). Additionally, Corcept said that >50% of patients experienced weight loss of >=5% from baseline (p<0.001), with mean reductions in waist circumference of 6.8 and 8.4 cm from baseline in women and men, respectively (p<0.001 for both). The most common adverse events were fatigue and nausea. Corcept said that 16 patients had serious adverse events, of which 6 were considered to be probably related to Corlux. Of the 16 patients who withdrew from the study, 7 discontinued due to adverse events and 7 withdrew consent or discontinued for other reasons, in addition to 2 patients who died from underlying metastatic disease. No deaths were attributed to treatment with Corlux. Data were presented at the Endocrine Society meeting in Boston. ...