Cirius Therapeutics Completes Enrollment in Phase 2b EMMINENCE Trial in NASH

May 2, 2018

Having recently completed a series A financing round of up to $40 million, Cirius Therapeutics announced on 5/2/2018 that it has reached its enrollment target in its Phase 2b EMMINENCE 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.

"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," said Howard Dittrich, M.D., chief medical officer of Cirius.

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.

Cirius' series A round was financed by a number of investors including: Frazier Healthcare Partners and Novo A/S in the financing were new investors Adams Street Partners and Renaissance Venture Capital Fund, as well as existing investors including Hopen Life Sciences Ventures.





CP Wire

Submit an article to cafepharma's CP Wire. Click here to find out more.

current feelings about your job

Please rate how you feel about your job this moment. 1 = "I hate my job" and 7 = "I love my job"
CAPTCHA
This question is for testing whether or not you are a human visitor and to prevent automated spam submissions.
Fill in the blank.