Tenax Therapeutics Phase 3 Trial Fails Primary Endpoint

Tenax Therapeutics reported that its Phase 3 LEVEL trial of oral levosimendan for pulmonary hypertension associated with heart failure with preserved ejection fraction failed to meet its primary endpoint. The drug did not produce the required improvement in the 6-minute walk distance, nor did it meet the key secondary endpoint regarding the Kansas City Cardiomyopathy Questionnaire total symptom score.

While the drug was generally safe and well tolerated, the efficacy failure caused company stock to fall. Prespecified subgroup analyses suggested a beneficial treatment effect in patients with greater disease burden, a finding supported by changes in pulmonary hemodynamic measures and cardiac biomarkers.

In response to the results, the company plans to request a Type C Meeting with the U.S. Food and Drug Administration. Tenax Therapeutics also intends to seek scientific consultation from the European Medicines Agency to discuss necessary revisions to the drug's registrational development.