Tenax Therapeutics reports result of prespecified blinded sample size assessment

Tenax Therapeutics (TENX) announced that the prespecified Blinded Sample Size Re-estimation of LEVEL demonstrated the trial is powered at well over 90% to detect a 25 meter change in 6-minute walk distance, the primary endpoint. Based on these results, Tenax confirmed the target enrollment remains unchanged, and reiterated that enrollment is expected to complete in the first half of 2026. LEVEL is an ongoing, registrational Phase 3 clinical trial evaluating TNX-103 in patients with pulmonary hypertension in heart failure with preserved ejection fraction in the United States and Canada. The prespecified, blinded review of the standard deviation in 6MWD change observed in the first 150 randomized, placebo-controlled patients, yielded a result of less than the assumed 55 meters. The Company also announced that it has initiated LEVEL-2, the second registrational study of TNX-103 in patients with PH-HFpEF. LEVEL-2 is a global, Phase 3, double-blind, randomized, placebo-controlled study of TNX-103. The clinical trial plans to enroll approximately 540 PH-HFpEF patients, randomized 2:1 to receive TNX-103 or placebo. The primary endpoint of the study is change from baseline in 6MWD at Week 26. Secondary endpoints include change from baseline in Kansas City Cardiomyopathy Questionnaire and New York Heart Association Functional Class. In addition, Tenax announced it will initiate a global, multi-center, long-term, open-label extension study. The OLE study will provide patients enrolled in levosimendan clinical trials continued access to TNX-103 after study completion and until potential availability of a commercialized product.