Cirius NASH candidate improves liver enzymes in Phase IIb

Cirius Therapeutics Inc. (Kalamazoo, Mich.) reported interim data from 328 evaluable patients with biopsy-proven non-alcoholic steatohepatitis (NASH) with fibrosis and no cirrhosis in the Phase IIb EMMINENCE trial showing that MSDC-0602K reduced liver enzymes from baseline to six months vs. placebo.

The double-blind, U.S. trial enrolled 402 patients to receive placebo or once-daily 62.5, 125 or 250 mg oral MSDC-0602K. Mid-dose MSDC-0602K led to placebo-adjusted reductions at six months of 14.3 U/L (p<0.001) in alanine aminotransferase (ALT) levels and 7.9 U/L (p=0.012) in aspartate aminotransferase (AST) levels. High-dose MSDC-0602K led to placebo-adjusted reductions at six months of 10.6 U/L (p=0.004) in ALT levels and 4 U/L (p-value not significant) in AST levels. Mid- and high-dose MSDC-0602K both significantly improved fasting glucose, HbA1c, insulin levels and homeostasis model assessment-insulin resistance (HOMA-IR) score from baseline to six months vs. placebo...