Tenax Therapeutics is advancing its lead program, levosimendan, for the treatment of pulmonary hypertension in patients with heart failure with preserved ejection fraction (PH-HFpEF). This condition affects over 2 million patients in the United States, representing roughly a quarter of all heart failure patients, and currently lacks approved therapies specifically for this population.
Levosimendan has already received regulatory approval in approximately 60 countries for the treatment of acute decompensated heart failure and has been evaluated in numerous clinical studies. The drug exhibits unique properties, including inotropic support and vasodilation, across various heart failure indications.
Phase II HELP Trial Results
Data from the Phase II HELP trial in PH-HFpEF patients demonstrated levosimendan's ability to prevent an increase in stress blood volume during physical exertion, thus reducing stress on the left ventricle. This effect led to a statistically significant increase in the six-minute walk distance following six intravenous infusions of levosimendan. The improvement in walk distance further increased when patients were switched to oral levosimendan in an open-label extension.
Phase III LEVEL Trial Underway
Tenax Therapeutics is currently enrolling patients in the Phase III LEVEL trial. The primary endpoint of this trial is the change in six-minute walk distance at week 12, with results anticipated in the second half of 2025. According to William Blair analyst Matt Phipps, achieving positive results of approximately a 25-meter change versus placebo would significantly de-risk the second Phase III trial required for regulatory approval and boost investor confidence in the program and market opportunity.
