SAN DIEGO and KALAMAZOO, Mich., May 2, 2018 /PRNewswire/ -- Cirius Therapeutics announced today that it has reached its enrollment target in its Phase 2bEMMINENCE trial for its lead program MSDC-0602K in more than 380 patients with NASH and liver fibrosis. The study is using liver biopsy at 12 months to measure changes in liver tissue, including resolution of NASH, reduction of fibrosis and changes in NAFLD activity score, for its primary and secondary endpoints. The study's endpoints include those identified as suitable for registration studies based on current FDA guidance. Interim data are anticipated in the second half of 2018 and final data in mid-2019.
"The fact that we reached our enrollment target ahead of schedule in one of the largest Phase 2b trials conducted in NASH is a strong testament to the hard work of our team as well as the keen interest from patients and investigators in MSDC-0602K," said Howard Dittrich, M.D., chief medical officer of Cirius. "MSDC-0602K offers a promising new approach to treating NASH that addresses underlying metabolic dysfunction, a fundamental driver of the disease, and we are encouraged by the strong support for this trial and believe that it reflects the interest in new, potentially disease-modifying, therapies for NASH."
In a previous clinical trial in patients with Type 2 diabetes, MSDC-0602 (free acid) was well-tolerated and was shown to improve parameters of glycemic control. The EMMINENCE trial will also evaluate glycemic control and other measures of insulin resistance, along with changes in liver enzymes, across three doses of MSDC-0602K and placebo.
"MSDC-0602K, with its mechanism focusing on the upstream metabolic cause of NASH, could potentially help millions of people who are suffering from NASH," said Stephen Harrison, M.D., the principal investigator of the trial. "The compound has been shown to modulate entry of pyruvate, an important component of cellular metabolism, into the mitochondria, and restoring balance to metabolism has the potential to reduce inflammation, steatosis and fibrosis."
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. Cirius is conducting a Phase 2b clinical trial called the EMMINENCE trial, to evaluate MSDC-0602K in patients with NASH and liver fibrosis. For more information about Cirius Therapeutics, visit www.ciriustx.com.