Tenax Therapeutics IncPhase 3 trial missed primary endpoint but subgroup analysis shows potential benefit, leading to uncertain regulatory path.

Tenax Therapeutics reported that additional analyses from its Phase 3 LEVEL trial suggest its oral levosimendan treatment, TNX-103, may benefit pulmonary hypertension patients with more limited exercise capacity, even though the trial failed its primary endpoint in the overall population. The company presented the findings at the European Society of Cardiology Congress in Munich, where it also revealed that the trial missed a key secondary endpoint measuring heart failure symptoms. In the full population of 241 patients with PH-HFpEF, TNX-103 did not significantly improve six-minute walking distance or Kansas City Cardiomyopathy Questionnaire scores. However, a prespecified analysis of 119 patients who could walk less than the trial median of 333 meters at baseline showed a statistically significant 26.3-meter improvement in walking distance and a 5.7-point improvement in symptom scores, exceeding the clinically meaningful threshold. Tenax plans to target this higher-risk subgroup in a follow-up trial called LEVEL-2, but the strategy carries substantial clinical and regulatory risk because the encouraging results came from a subset of the original study population.
Tenax Therapeutics IncPhase 3 trial missed primary endpoint but subgroup analysis shows potential benefit, leading to uncertain regulatory path.