Pipeline

MSDC-0602K Clinical Development

Cirius has completed a double-blind, dose-ranging Phase 2b clinical trial, the EMMINENCE trial, in 402 NASH subjects with fibrosis, approximately 50% of whom were also diagnosed with Type 2 diabetes. In the trial, we evaluated hepatic histological changes measured by biopsy, changes in liver and metabolic functions measured by the circulating liver enzymes (ALT, AST, GGT, ALP), markers of liver fibrosis, glycemic control and safety and tolerability.

This study showed that MSDC-0602K could be dosed to full insulin sensitizing pharmacology seen with the first generation insulin sensitizers, but without the dose-limiting side effects that occurred with the first generation insulin sensitizers. MSDC-0602K was shown to improve non-invasive markers of liver health, glycemic control, and importantly, led to the reduction of chronically elevated fasting insulin levels. Cirius is now planning Phase 3 studies in NAFLD/NASH with Type 2 Diabetes.

We intend to leverage our expertise in the field of liver and metabolic diseases to expand our pipeline through strategic licensing, collaborations and/or acquisitions.