MSDC-0602K Clinical Development
Cirius has fully enrolled a Phase 2b clinical trial, the EMMINENCE trial, in 402 NASH subjects with fibrosis, approximately 50% of whom have also been diagnosed with Type 2 diabetes. EMMINENCE is a 12 month, randomized, double-blind, placebo-controlled trial evaluating three oral doses of MSDC-0602K. In the trial, we will evaluate hepatic histological changes measured by biopsy, changes in liver and metabolic functions measured by the circulating liver enzymes ALT and AST, markers of liver fibrosis, glycemic control and safety and tolerability. Our biopsy-based endpoints include those currently being used as primary endpoints in Phase 3 clinical trials of other NASH development candidates.
We expect to report final results, including 12-month liver biopsy data from the EMMINENCE trial, in the second half of 2019. These data will inform our Phase 3 development plans for the treatment of NASH with fibrosis as well as potential clinical development in other indications. Based on the final results of the EMMINENCE trial, if successful, we plan to initiate a Phase 3 program in early 2020.