{"id":821990,"date":"2025-03-05T08:46:05","date_gmt":"2025-03-05T13:46:05","guid":{"rendered":"https:\/\/www.marketnewsdesk.com\/index.php\/tenax-therapeutics-expands-phase-3-level-program-advancing-two-tnx-103-oral-levosimendan-registrational-studies-for-the-treatment-of-ph-hfpef\/"},"modified":"2025-03-05T08:46:05","modified_gmt":"2025-03-05T13:46:05","slug":"tenax-therapeutics-expands-phase-3-level-program-advancing-two-tnx-103-oral-levosimendan-registrational-studies-for-the-treatment-of-ph-hfpef","status":"publish","type":"post","link":"https:\/\/www.marketnewsdesk.com\/index.php\/tenax-therapeutics-expands-phase-3-level-program-advancing-two-tnx-103-oral-levosimendan-registrational-studies-for-the-treatment-of-ph-hfpef\/","title":{"rendered":"Tenax Therapeutics Expands Phase 3 LEVEL Program, Advancing Two TNX-103 (Oral Levosimendan) Registrational Studies for the Treatment of PH-HFpEF"},"content":{"rendered":"
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\n Amendment to Enlarge Phase 3 LEVEL Study, Increasing Statistical Powering, Accepted by FDA, Expected to be Fully Enrolled Around Year End 2025<\/em>\n <\/p>\n

\n Agreement by FDA to Initiate Second Global Phase 3 Study, LEVEL-2, with First Patient Expected to be Enrolled this Year<\/em>\n <\/p>\n

CHAPEL HILL, N.C., March 05, 2025 (GLOBE NEWSWIRE) — Tenax Therapeutics, Inc. (Nasdaq: TENX) (\u201cTenax Therapeutics\u201d or the \u201cCompany\u201d), a Phase 3, development-stage pharmaceutical company using clinical insights to develop novel cardiopulmonary therapies, today announced the U.S. Food and Drug Administration (FDA) has completed their review of Tenax Therapeutics\u2019 updated Phase 3 development plan for TNX-103 (oral levosimendan), including an Amendment to expand enrolment and increase the power of the ongoing Phase 3 LEVEL study, and the protocol for LEVEL-2, Tenax Therapeutics\u2019 second registrational Phase 3 study. The Company today announced it expects to enroll 230 patients in the LEVEL study, increasing the statistical powering of the study to over 95%. LEVEL-2, a global study, is expected to commence in 2025.<\/p>\n

\u201cWe are increasing our investment in the clinical development plan for TNX-103 by expanding the ongoing LEVEL study and accelerating our plans to initiate the second registrational study, LEVEL-2. With the momentum provided from our $100 million financing in August 2024 and alignment with the FDA, we are now able to execute on our plan to advance these two Phase 3 registrational studies for TNX-103 in parallel. LEVEL is enrolling well: we are confident that, with more than 50 North American sites already activated, we can complete enrollment of this upsized study around year end, while also commencing the global LEVEL-2 study later this year,\u201d said Chris Giordano, President and Chief Executive Officer of Tenax Therapeutics. \u201cWe expect these two registrational studies will satisfy the requirements, including the safety data expectations, to file in the U.S. and other geographies. We are funded well beyond our projected date for the release of topline LEVEL data, positioning us to advance the development of TNX-103 and improve the quality of life for patients living with PH-HFpEF.\u201d<\/p>\n

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\n LEVEL Study Expansion Enhances Statistical Power<\/u>
\n <\/strong>\n <\/p>\n

The LEVEL study, evaluating TNX-103 for the treatment of PH-HFpEF, will expand enrollment from 152 to at least 230 patients, increasing the statistical powering of the study. The Company is on track to enroll the first 150 subjects in the first half of 2025, expects to complete enrollment by around the end of 2025, and expects to present topline data from the LEVEL study in the middle of 2026.\u00a0\u00a0<\/p>\n

As of late February 2025, blinded LEVEL data reveal TNX-103 to be well-tolerated in patients with PH-HFpEF:<\/p>\n