First patient in phase III LEVEL study evaluating TNX 103 (oral levosimendan) for the treatment of pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF)

“We are pleased to announce the enrollment of our first patient in the Phase III LEVEL study, and delighted we are progressing rapidly from identification to initiation of investigator sites,” said Chris Giordano, President and Chief Executive Officer of Tenax Therapeutics. “The Tenax team and our CRO and other research partners have worked tirelessly to reach this milestone. Our study is generating enthusiasm among North American cardiologists who treat PH-HFpEF. FDA has approved no drugs, to date, for this disease.”

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. 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 III studies that will evaluate TNX 103 (oral levosimendan) for the treatment of pulmonary hypertension in heart failure with preserved ejection fraction (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 III program for TNX 103 has been designed to exceed the minimal clinically important difference, and satisfy the FDAs request for subject drug exposure of 300 patients for 6 months and 100 patients for 1 year (these are minimum requirements per ICH guidelines).

About Levosimendan (TNX 101, TNX 102, TNX 103): Levosimendan is a unique potassium ATP channel activator and calcium sensitizer that affects the heart and vascular system through multiple mechanisms of action. Initially discovered and developed by Orion Corporation in Finland, intravenous levosimendan is approved in 58 countries outside the United States for use in hospitalized patients with acutely decompensated heart failure. Tenax Therapeutics has North American rights to develop and commercialize IV (TNX 101), subcutaneous (TNX 102), and oral (TNX 103) formulations of levosimendan. Results of Tenax Therapeutics’ Phase II HELP trial of levosimendan in patients with pulmonary hypertension (PH) and heart failure with preserved ejection fraction (HFpEF) demonstrated that IV levosimendan produces potent dilation of the central and pulmonary venous circulations which translates into an improvement in exercise capacity, a discovery that forms the basis for LEVEL, the Phase III investigation of Tenax Therapeutics’ potential groundbreaking therapy. To date, no other drug therapy has improved exercise tolerance in patients with PH associated with HFpEF, “a growing epidemic with high morbidity and mortality and no treatment. The clear unmet need and lethal nature of PH-HFpEF must be met with novel solutions at all levels of therapeutic development.” (AHA Scientific Advisory, “A Call to Action,” 2022).