Modifying Metabolism
for the Treatment of NASH
Cirius Therapeutics, a clinical-stage pharmaceutical company, is developing MSDC-0602K, a novel metabolic treatment for nonalcoholic steatohepatitis (NASH). MSDC-0602K is currently being evaluated in a Phase 2b clinical trial. Through its novel mechanism of action that reduces insulin resistance and restores metabolic balance, MSDC-0602K has potential to resolve the underlying pathophysiology of NASH.
The Next Big Global Epidemic
Million Americans
Million Americans
Million Americans
NASH is a severe, rapidly progressive form of nonalcoholic fatty liver disease (NAFLD) that has been identified as the next big global epidemic. NASH, characterized by buildup of fat and inflammation in the liver, may be accompanied by fibrosis, and can progress to life-threatening cirrhosis or liver cancer. Currently, there are no approved therapies. Approximately 6.5 million adults in the U.S. and the five major European countries have advanced NASH. The size of the global market for NASH treatments is estimated to be $35 to $40 billion by 2025.
Insulin resistance, a root cause of type 2 diabetes, is considered a key factor in the initiation and perpetuation of NASH. NASH patients with diabetes have been shown to have more advanced fibrosis, are prone to a more rapid progression of their fibrosis and have a two- to three-fold higher risk of overall mortality. Approximately 50% of patients with NASH have type 2 diabetes – and the presence or absence of diabetes appears to be a critical predictor of poor clinical outcomes in NASH.
We believe that a successful treatment for NASH must address the pathophysiology of NASH, including the metabolic dysfunction that results in insulin resistance.
Metabolic dysfunction and insulin resistance, a root cause of type 2 diabetes, are key factors in the initiation and perpetuation of NASH.
NASH patients with diabetes have been shown to have more advanced fibrosis, are prone to a more rapid progression of their fibrosis, and have a two- to three-fold higher risk of overall mortality.
MSDC-6062K is currently in a Phase 2b clinical trial – the EMMINENCE trial – to evaluate the compound’s safety, tolerability and efficacy in patients with NASH. The EMMINENCE trial is a randomized, double-blinded study of three doses of MSDC-0602K (62.5, 125 and 250 mg) or placebo given orally, once daily, for a period of one year to subjects with biopsy-proven NASH with fibrosis. The trial will not only allow a meaningful evaluation of three doses of the drug on the various histological parameters of NASH but also provide important information on the drug’s effects on insulin resistance and other metabolic parameters as well as the drug’s safety.
The primary endpoint of this clinical trial is reduction in the NASH pathology as assessed in direct examination of liver biopsies by an expert pathologist.