Tenax Therapeutics is poised to announce Phase 3 study results for levosimendan, an oral treatment designed for pulmonary hypertension due to heart failure with preserved ejection fraction, or PH-HFpEF. The LEVEL study is evaluating the drug versus placebo in patients with this chronic, progressive condition in which the heart pumps normally but muscle stiffness prevents proper filling, causing blood backup and elevated lung pressure. Symptoms include shortness of breath during daily activities, fluid accumulation, and fatigue.
The study’s primary efficacy endpoint measures exercise capacity using a six-minute walk test after 12 weeks of treatment. Tenax requires approximately a 15-meter improvement over placebo to achieve statistical significance, with a 20-25 meter benefit or greater considered a strong result. A secondary endpoint assesses symptom improvement and quality of life using the Kansas City Cardiomyopathy Questionnaire. Results are expected within three weeks via press release, with a late-breaker presentation slot reserved for Aug. 29 at the European Society of Cardiology annual meeting.
Tenax’s therapeutic approach differs from previous unsuccessful treatments by attempting to reduce blood volume returning to the heart rather than increasing pumping capacity or widening blood vessels. An injectable levosimendan formulation is approved in Europe for acute heart failure. The company’s Phase 2 study using an intravenous version showed mixed results, with nearly a 17-meter walk improvement compared to a 13-meter decline for placebo, but failed to positively affect heart pressure levels.
No drugs are currently approved specifically for PH-HFpEF treatment. Analysts estimate approximately 2 million Americans have the condition, representing a substantial untapped market. Peak annual sales could reach $2.5 billion to $5.4 billion in the U.S., with additional international potential. The company has no alternative products in development, making this single study outcome potentially transformative or devastating for Tenax’s future. A second Phase 3 trial called LEVEL-2 is underway with patient enrollment expected to complete late next year.
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