Cirius Therapeutics, a clinical-stage pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and metabolic diseases, today announced data from its recently completed 12-month Phase 2b EMMINENCE clinical trial of MSDC-0602K for the treatment of non-alcoholic steatohepatitis (NASH).
SAN DIEGO and KALAMAZOO, Mich., Nov. 8, 2019 /PRNewswire/ -- Cirius Therapeutics, a clinical-stage pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and metabolic diseases, today announced data from its recently completed 12-month Phase 2b EMMINENCE clinical trial of MSDC-0602K for the treatment of non-alcoholic steatohepatitis (NASH). The data showed MSDC-0602K to be well-tolerated and demonstrated improvements in liver enzyme levels and markers of glycemic control, as well as dose-dependent trends for improvement in liver histology in NASH patients with or without Type 2 diabetes. Results will be presented in a late-breaking oral presentation at The Liver Meeting® on November 11, 2019 and will be published concurrently in the Journal of Hepatology. “The results of this study consistently showed that treatment with MSDC-0602K led to significant improvements in glycemic control and laboratory measures of liver injury,” said Bob Baltera, Cirius’ chief executive officer. “While the histopathologic effects did not reach statistical significance in the primary analysis of this Phase 2 study, we are very encouraged by the consistent evidence of dose response across numerous measures, including biopsy. These results support the potential of an insulin sensitizer to improve liver histopathology in an adequately powered Phase 3 trial and, ultimately to improve cardiovascular outcomes in patients with NASH and diabetes.” MSDC-0602K, a second-generation, oral insulin sensitizer, is designed to selectively modulate the mitochondrial pyruvate carrier (MPC) while minimizing direct PPAR-gamma activation. The MPC mediates at the cellular level the effects of overnutrition, a major cause of non-alcoholic fatty liver disease NAFLD/NASH and Type 2 diabetes. In preclinical studies, modulation of the MPC has been shown to improve insulin sensitivity, lipid metabolism, and inflammation. EMMINENCE Design Results of Biopsy Trend Toward Improvement Biopsy results- primary analysis
Biopsy results- post hoc exploratory analysis
Statistically Significant Improvement in Liver Enzymes
*ALT upper limit of normal defined as 19 U/L and 30 U/L for women and men, respectively Glycemic Control Data Shows Robust Improvements Dr. Stephen Harrison, EMMINENCE trial principal investigator, commented, “Insulin resistance is a common feature of the NASH population, and the results on objective measures showing MSDC-0602K’s comprehensive improvements on insulin handling are very encouraging. There is an opportunity with this agent to directly evaluate the impact on cardiovascular outcomes without relying solely on the surrogate liver biopsy endpoints, which historically have been hampered by sampling error and variability in reading.” Treatment with MSDC-0602K Appears Well-Tolerated Based on the results from EMMINENCE, Cirius plans to meet with regulatory authorities to discuss design for the planned Phase 3 study for MSDC-0602K. “Insulin resistance is a cause of both diabetes and NAFLD, which lead to increased cardiovascular risk; therefore, a safe compound that increases a body’s sensitivity to insulin has the potential to address the underlying pathophysiology of both diseases,” said Howard Dittrich, M.D., chief medical officer of Cirius."These results indicate that MSDC-0602K can be dosed to full insulin-sensitizing pharmacology without dose-limiting side effects, with the greatest effects in patients with more severe liver injury and poorer glycemic control, a group who have an elevated risk for adverse cardiovascular outcomes.” About Cirius Therapeutics For more information about Cirius Therapeutics, visit www.ciriustx.com.
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