Cirius Therapeutics Announces Presentation of Interim Data from Phase 2b Clinical Study of MSDC-0602K at The International Liver Congress 2019
SAN DIEGO and KALAMAZOO, Mich., April 12, 2019 /PRNewswire/ -- Cirius Therapeutics announced today that positive results from an interim analysis of exploratory endpoints from the EMMINENCE trial, its ongoing Phase 2b clinical trial evaluating MSDC-0602K in 402 patients diagnosed with non-alcoholic steatohepatitis (NASH) with fibrosis, were presented at The International Liver Congress™ 2019, occurring in Vienna, Austria, from April 10 to 14, 2019.
The interim analysis, which was conducted in the first 328 patients to reach their six-month follow-up visit, demonstrated that patients treated with MSDC-0602K had significant improvements from baseline in measures of liver function and insulin resistance at six months. Key findings from the interim analysis include improvements in liver enzymes, with placebo-corrected reductions at 6 months of 14.3 U/L (p<0.001) and 7.9 U/L (p=0.012) in ALT and AST, respectively, in the 125mg cohort, and 10.6 U/L (p=0.004) and 4.0 (NS) in ALT and AST, respectively, in the 250mg cohort.
In addition, in patients with Type 2 diabetes, all doses of MSDC-0602K were associated with significant improvements in HbA1c, a marker of glycemic control. In this interim analysis, the overall rate of treatment emergent adverse events was similar across placebo and all MSDC-0602K cohorts. A modest, dose-dependent increase in body weight was seen in MSDC-0602K treated subjects, a finding seen with insulin and with other therapies that seek to improve insulin resistance. The rate of peripheral edema observed at six months was similar to that observed at baseline and was comparable across placebo and all MSDC-0602K cohorts.
"We believe these interim results from the EMMINENCE trial, the largest Phase 2b clinical trial to include paired biopsies ever conducted in NASH, support MSDC-0602K's potential to be used in the treatment of NASH with fibrosis, including for those patients with Type 2 diabetes," said Bob Baltera, president and CEO of Cirius Therapeutics. "The improvements in hepatic enzymes observed to date are impressive, especially when combined with the meaningful improvements observed in glycemic control, and we are eagerly anticipating the full data readout, which we expect will occur in the second half of this year."
MSDC-0602K, a second-generation insulin sensitizer, is designed to selectively modulate the mitochondrial pyruvate carrier (MPC), which at the cellular level mediates the effects of overnutrition, a major cause of NASH and other metabolic disorders.
Dr. Stephen Harrison, the principal investigator in the EMMINENCE trial, presented the interim results at The International Liver Congress during the NAFLD-Clinical Therapy Session held on April 12, 2019 at 5:30 p.m. CET (Abstract PS-111).
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