Tenax Therapeutics, Inc. announced that the first patient has enrolled in the Company's Phase 3 level Study (LEVosimendan to Improve Exercise Limitation in PH-HFpEF Patients) (NCT05983250). 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 (TNX-103) being evaluated in level, as well as I.V. and subcutaneous formulations, in patients with PH-HFpEF.

The level study will evaluate six-minute walking distance (6MWD) 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 (these are minimum requirements per ICH guidelines).