Phase III LEVO-CTS trial of levosimendan failed to meet primary endpoints in low cardiac output syndrome- Tenax Therapeutics

Tenax Therapeutics announced top-line results from its Phase III LEVO-CTS trial of levosimendan in low cardiac output syndrome (LCOS). The study did not achieve statistically significant reductions in the dual endpoint of death or use of a mechanical assist device at 30 days, nor in the quad endpoint of death, myocardial infarction, need for dialysis, or use of a mechanical assist device at 30 days. However, the study demonstrated statistically significant reductions in two of three secondary endpoints including reduction in low cardiac output syndrome and a reduction in postoperative use of secondary inotropes. Patient visits for data on death through day 90 have not yet been completed.

The Company has a meeting scheduled with the U.S. Food and Drug Administration (FDA) to review the preliminary trial data and discuss a path forward to bring this potentially lifesaving treatment to the benefit of patients undergoing serious cardiac surgery. Analyses of the LEVO-CTS trial results are ongoing and will be presented at the American College of Cardiology 66th Annual Scientific Session.