Cirius Therapeutics is a new clinical stage company formerly known as Octeta Therapeutics to advance the clinical development of MSDC-0602K, a new therapeutic compound currently in a Phase 2 clinical trial (the EMMINENCE™ Trial) for the treatment of nonalcoholic steatohepatitis (NASH). See www.ciriustx.com for more information.
NASH is the severe form of non-alcoholic “fatty liver disease,” a disease which has been identified as the next big global epidemic. Approximately 6.5 million adults in the U.S. and the five major European countries have advanced NASH, and analysts at Deutsche Bank recently estimated the size of the global market for NASH treatments to be $35 billion to $40 billion by 2025.
Nonalcoholic fatty liver disease causes the liver to swell with fat, similar to the liver damage that is seen in heavy drinkers. However, in the case of nonalcoholic fatty liver disease, the damage is done not by alcohol, but by poor diet and excess weight.
Of note, a root cause of type 2 diabetes – insulin resistance – is considered a key factor in the initiation and perpetuation of NASH. In fact, 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 (Pagadala and McCullough, Clin Liver Dis. 2012 Aug;16(3): 487–504). So, it is not surprising that an estimated 60%-80% of NASH patients have type 2 diabetes, and the presence of diabetes appears to be the best predictor of poor clinical outcomes in NASH (PLOS ONE, DOI:10.1371/journal.pone.0128774, June 17, 2015).
About the EMMINENCE Trial
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 to subjects with biopsy proven NASH with fibrosis and no cirrhosis. More information can be found at: NCT02784444.