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Tenax Therapeutics presented comprehensive results from its Phase 3 LEVEL trial for TNX-103 (oral levosimendan) in…
TENXTenax Therapeutics, Inc.
Tenax Therapeutics presented comprehensive results from its Phase 3 LEVEL trial for TNX-103 (oral levosimendan) in patients with pulmonary hypertension associated with heart failure with preserved ejection fraction (PH-HFpEF). The primary endpoint, change in six-minute walk distance (6MWD), did not reach statistical significance (treatment difference 3.5 m; p = 0.63). However, the drug significantly reduced NT-proBNP by approximately 49% and right ventricular systolic pressure (RVSP) by 3.5 mmHg. Post-hoc analyses indicated that patients with lower baseline exercise capacity (<333 m) experienced a clinically meaningful improvement of +26.3 meters in 6MWD compared to placebo. Management attributes the neutral primary result to protocol design flaws regarding patient selection and is using these insights to de-risk the upcoming LEVEL-2 trial by enriching for sicker patients with greater room for functional improvement. Tenax Therapeutics operates in the biopharmaceutical industry, developing treatments for heart failure.