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Tenax Therapeutics Enrolls First Patient in Phase 3 LEVEL Study Evaluating TNX-103 (Oral Levosimendan) for the Treatment of Pulmonary Hypertension in Heart Failure with Preserved Ejection Fraction (PH-HFpEF)
Over 40 sites (U.S. and Canada) have agreed to participate in the LEVEL study LEVEL is a randomized, controlled Phase 3 trial of 152 patients, and will
About this update from Tenax Therapeutics, Inc.
[{"type":"text","content":"Over 40 sites (U.S. and Canada) have agreed to participate in the LEVEL study LEVEL is a randomized, controlled Phase 3 trial of 152 patients, and will recruit patients primarily from leading research centers with large PH-HFpEF populations Tenax forecasts topline LEVEL data will be available second half of 2025 CHAPEL HILL, N.C., Feb. 07, 2024 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, today 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). “We are pleased to announce the enrollment of our first patient in the Phase 3 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. “We are thrilled to be working with some of the largest, most prestigious cardiovascular research institutes in North America, if not the world,” said Stuart Rich, M.D., Chief Medical Officer of Tenax Therapeutics. “Nine of the ten investigators who randomized patients in our previous levosimendan study – at sites like Mayo, Harvard, Northwestern – have agreed to enroll patients in LEVEL. This reflects a growing interest among these academic medical experts in the novel mechanism of ...