Tenax Therapeutics, Inc. announced today the topline results of its Phase 3 LEVEL trial, which evaluated TNX-103 (oral levosimendan) in patients with pulmonary hypertension associated with heart failure with preserved ejection fraction (PH-HFpEF), Group 2 of the World Health Organisation (WHO) pulmonary hypertension classification. The trial did not meet its primary endpoint — improvement in 6-minute walk distance versus placebo — nor its key secondary endpoint, improvement in the Kansas City Cardiomyopathy Questionnaire total symptom score. However, some subgroup analyses pointed to a substantial treatment benefit in patients with a greater disease burden, backed by clinically meaningful changes in predefined cardiac biomarkers and pulmonary hemodynamic measures across the trial population as a whole. TNX-103 was generally safe and well tolerated, with serious adverse events and adjudicated clinical worsening events evenly balanced across the treatment arms. On the strength of these results, Tenax plans to request a Type C Meeting with the U.S. Food and Drug Administration (FDA) to discuss how to revise the ongoing registrational development of TNX-103 for pulmonary hypertension associated with heart failure with preserved ejection fraction.
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