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Tenax Therapeutics Announces FDA Clearance of IND for TNX-103 (oral levosimendan) for the Treatment of Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF), Initiation of Phase 3 sites expected 2023
First Phase 3 study of TNX-103 in PH-HFpEF patients to start in 4Q 2023 (The LEVEL Study)FDA agreement that 6MWD will be the primary endpoint for both Phase 3
About this update from Tenax Therapeutics, Inc.
[{"type":"text","content":"First Phase 3 study of TNX-103 in PH-HFpEF patients to start in 4Q 2023 (The LEVEL Study)FDA agreement that 6MWD will be the primary endpoint for both Phase 3 studies Phase 3 program designed to satisfy FDA’s request for subject drug exposure of 300 patients for 6 months, 100 patients for 1 year (minimum requirements per ICH guidelines)No FDA requirement for a cardiovascular outcomes trial Oral levosimendan use in PH-HFpEF is protected by USPTO granted patent that will not expire until the end of 2040There are no FDA-approved treatments for PH-HFpEF, with an estimated prevalence of more than 2,000,000 patients in North America by 2030. CHAPEL HILL, N.C., Nov. 13, 2023 (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, announced today that the U.S. Food and Drug Administration (FDA) has reviewed and cleared the Company’s Investigational New Drug (IND) Application for TNX-103 (oral levosimendan) for the treatment of pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF), enabling Tenax to proceed with the first of two Phase 3 studies. The LEVEL Study (LEVosimendan to Improve Exercise Limitation in PH-HFpEF Patients) is expected to launch in the fourth quarter of 2023. “We could not be more pleased with the results of our collaborative, productive discussions with the FDA, which provide a clear path to starting LEVEL, including mutual alignment with respect to the primary efficacy endpoint and expected patient enrollment,” said Chris Giordano, President and Chief Executive Officer of Tenax Therapeutics. “Importantly, Tenax will not be required to conduct a long-term, cardiovascular outcomes trial, which should significantly reduce our costs and time to registration for TNX-103. With no approved therapies currently available in the U.S., physicians, patients and regulators increasingly recognize the significant unmet need of patients who suffer from PH-HFpEF.” “Despite many therapeutic advancements across a wide spectrum of cardiovascular diseases, there are no FDA-approved treatments for PH-HFpEF, a condition impacting millions globally,” said Sanjiv Shah, MD, Stone Professor and Director of the HFpEF Program at No...