Tenax Therapeutics Inc (NASDAQ:TENX) recently announced the top-line results pertaining to Phase 3 LEVO-CTS trial. The company said that the study failed to achieve the desired results in dual endpoint target. Tenax Therapeutics had hoped the study to achieve considerable reduction in dual endpoint of the use or death of mechanical assist device for at least a month. However, the study failed to achieve this. Also, the study failed to achieve quad endpoint of death, dialysis requirement, myocardial infarction or application of mechanical assist device for a period of at least a month.
The achievable and unachievable results
Albeit the study failed to achieve these results, but according to the company, it did manage to depict “statistically significant” decrease in about two of three secondary endpoints, which also included low cardiac output syndrome (LCOS). Improvement was also observed in postoperative use of secondary inotropes reduction.
Meanwhile, the company also observed that the patients visit mandatory for data on death for a period of 90 days has missed the deadline. A meeting with the FDA is lined up, in the meanwhile. The U.S. Food and Drug Administration will now review preliminary trial data, while also discussing the future course of action to make possible, what is called, a “potentially lifesaving treatment.” The treatment is meant to bring the advantage of serious cardiac surgery for the patients.
The disappointment and surprise follows
On this account, the company CEO, John Kelley said, “We are disappointed and surprised by the top-line results from this trial, especially given the promising results from earlier published clinical trials.” He added that the company is looking for the potential of reduction in incidence of LCOS. Apart from this, it is also studying postoperative secondary inotropes application. Both these, according to the CEO, are vital for the company from clinical point of view.
The CEO adds that the company is focused on bringing this life-saving treatment to ground. On 19 March 2017, the company hopes to present the analysis of its LEVO-CTS trial results, which are still in process.