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Tenax Therapeutics announced topline results from its Phase 3 LEVEL clinical trial of TNX-103 (oral levosimendan) in…
TENXTenax Therapeutics, Inc.
Tenax Therapeutics announced topline results from its Phase 3 LEVEL clinical trial of TNX-103 (oral levosimendan) in patients with pulmonary hypertension due to heart failure with preserved ejection fraction (PH-HFpEF). The trial failed to meet its primary endpoint, showing no statistically significant improvement in the 6-minute walk distance versus placebo. However, prespecified subgroup analyses revealed a significant treatment effect in patients with higher disease burden, specifically those with baseline walk distances below the median of 333 meters, who improved by 26.3 meters compared to placebo. The drug also demonstrated strong biological activity, reducing NT-proBNP by 49% and right ventricular systolic pressure by 3.5 mmHg in the overall population. Tenax intends to request a Type C meeting with the FDA to discuss revising its development plan for TNX-103 based on these findings. The company operates as a clinical-stage pharmaceutical firm developing cardiopulmonary therapies.