Tenax Therapeutics enrolls first patient in Phase 3 study of TNX-103

The company stated: “Tenax Therapeutics announced that the first patient has enrolled in the Company’s Phase 3 LEVEL Study. As previously disclosed, the FDA does not require Tenax conduct a long-term, cardiovascular outcomes trial in this population, significantly reducing the costs and time for the registration of TNX-103. The extensive levosimendan patent estate includes protections through at least 2040 of all therapeutic doses of the proprietary oral formulation being evaluated in LEVEL, as well as I.V. and subcutaneous formulations, in patients with PH-HFpEF. We believe this positions Tenax, and potential strategic partners, to maximize the commercial potential of this unique, first-in-class therapy. The LEVEL study is the first of two planned Phase 3 studies that will evaluate TNX-103 for the treatment of pulmonary hypertension in heart failure with preserved ejection fraction. The LEVEL study will evaluate six-minute walking distance as the primary endpoint, and will enroll a total of 152 patients. The Phase 3 program for TNX-103 has been designed to exceed the minimal clinically important difference, and satisfy the U.S. Food and Drug Administration’s request for subject drug exposure of 300 patients for 6 months and 100 patients for 1 year.”