TENAX Therapeutics reported a comprehensive LEVEL trial update showing a 49% reduction in NT-proBNP and a 3.5 mmHg decline in pulmonary arterial pressure. The primary endpoint was not statistically significant, but the company said baseline exercise limitation identified patients with greater improvement and is using those findings to reshape the LEVEL-2 levosimendan development program.

Key Highlights

  • Pulmonary arterial pressure declined 3.5 mmHg during the 12-week blinded assessment.
  • The phase 3 study included 241 participants, with 120 receiving TNX-103 and 121 receiving placebo.
  • TENAX Therapeutics said LEVEL findings are being used to refine patient selection for LEVEL-2.

TENAX Therapeutics, Inc. (NASDAQ: TENX) released a comprehensive LEVEL clinical-trial update showing a 49% reduction in NT-proBNP, while the study’s primary endpoint did not reach statistical significance. The results update covers the company’s levosimendan development program and was made public on September 9, 2026. TENAX said the findings are being used to reshape the design and patient-selection strategy for LEVEL-2. The company presented the material at the 2026 Cantor Global Healthcare Conference. The full investor presentation was published alongside the conference presentation.

LEVEL Results Add Heart-Pressure Data

The 12-week blinded assessment showed a 3.5 mmHg decline in pulmonary arterial pressure, measured by right ventricular systolic pressure. The presentation also described improvements across echocardiographic measures of right-ventricle support. NT-proBNP, a measure of cardiac wall stress, fell 49%. TENAX linked the reduction to lower filling pressures involving both sides of the heart, alongside reductions in central venous and pulmonary arterial pressure. The study evaluated TNX-103, an oral formulation of levosimendan, against placebo. The phase 3 trial enrolled 241 participants, with 120 in the TNX-103 arm and 121 in the placebo arm. Baseline characteristics included a mean age of 69.1 years across the overall population. The overall mean baseline six-minute walk distance was 319.5 meters.

Exercise Limitation Shaped Response

The presentation identified baseline six-minute walk distance as the strongest predictor of improvement in that measure. Participants with greater exercise limitation recorded the largest treatment effect, with an improvement of more than 25 meters over 12 weeks. The update said the six-minute walk-distance results were comparable to those from HELP, with both results exceeding 25 meters. It also said NT-proBNP levels at baseline were associated with exercise improvement, while the reduction in right ventricular systolic pressure was greatest among patients with more severe exercise Impairment at baseline. The primary endpoint result was neutral. TENAX attributed that outcome in the presentation to the inclusion of too many participants with relatively high baseline walking distances, leaving limited room for measurable improvement. Treatment-emergent adverse events were described as similar between populations below and above the median baseline walking distance. The company said the results support enriching LEVEL-2 for patients with greater functional limitation.

LEVEL-2 Patient Selection Reset

The planned approach focuses on selecting patients whose baseline exercise limitation leaves greater scope for improvement. The presentation said patients with more functional limitation achieved a clinically meaningful exercise improvement of more than 26 meters over 12 weeks. It also stated that treatment effects improved as baseline six-minute walk distance declined. A LEVEL-2 protocol design paper was identified as forthcoming. The presentation also pointed to additional publications and scientific presentations in 2026 and 2027, including a primary paper and appearances at HFSA, AHA, CVCT and THT.