Cirius Therapeutics' Preclinical Data Demonstrates Potential for Lead Drug Candidate MSDC-0602K in NASH

Cirius Therapeuticsannounced today that it presented a late-breaking poster describing the activity of the company's lead drug MSDC-0602K in a three-dimensional bioprinted human tissue model of NASH at The International Liver Congress™ - occurring in Paris, France from April 11-15, 2018.

The poster, entitled "A human in vitro three-dimensional bioprinted tissue system can be used to model nutritional damage and protective effects of MSDC-0602K, a novel modulator of the mitochondrial pyruvate carrier" presented work performed using Organovo's (NASDAQ: ONVO) 3D bioprinted human liver tissue and was presented by Dr. Jerry Colca from Cirius Therapeutics.

The research demonstrated that adding fructose (sugar) and fatty acids to three-dimensional bioprinted human liver tissue produced NASH-type liver pathology, including steatosis, inflammation, ballooning and fibrosis. Addition of MSDC-0602K to the tissue showed evidence of reduced disease progression, including reductions in collagen deposition and stellate cell activation, in the liver model.

"The data shown in this human liver model demonstrates conclusively that oversupply of nutrients leads directly to NASH-like pathology, including fibrosis," said Dr. Colca. "In addition, we see in this 3-D tissue model evidence that treatment with MSDC-0602K, which modulates metabolism by slowing the transport of the important metabolic intermediate pyruvate into the mitochondria, reduces signs of NASH. This supports our thesis that restoring nutritional balance on a cellular level has potential to treat NASH."

This work follows recently published work demonstrating that attenuation of pyruvate metabolism with MSDC-0602K via modulation of the mitochondrial pyruvate carrier (MPC) can both prevent and reverse liver fibrosis.

"The ability to model human liver disease and drug intervention with our technology is a powerful tool for helping companies such as Cirius evaluate their drug candidates for the treatment of NASH," Paul Gallant, general manager, Organovo. "As the results of this research show, it can also yield valuable insights about potential biomarkers that can be monitored during liver disease progression."

About MSDC-0602K

MSDC-0602K is an oral, once-daily next-generation small molecule that restores metabolic balance at its root -- through mitochondrial function -- and therefore increases the body's sensitivity to insulin, the hormone that is the master regulator of metabolism. MSDC-0602K, which modulates the entry of pyruvate into the mitochondria, has the potential to correct the metabolic disturbance that is a proximate cause of NASH. Cirius is currently enrolling the EMMINENCE trial, a Phase 2b study of MSDC-0602K in NASH. This randomized study is comparing three doses of MSDC-0602K to placebo in NASH patients with fibrosis, and the study includes endpoints identified as suitable for registration studies based on current FDA guidelines.

About Cirius Therapeutics:

Cirius Therapeutics is a clinical-stage pharmaceutical company focused on developing therapies to treat liver disease. The company's lead product is MSDC-0602K, a molecule that restores metabolic balance at its root - through mitochondrial function - and therefore reduces insulin resistance. Cirius is actively enrolling patients in a Phase 2b clinical trial called the EMMINENCE trial, to evaluate MSDC-0602K in patients with NASH and liver fibrosis

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