News | FDA | November 27, 2023

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) 

 

First Phase 3 study of TNX-103 in PH-HFpEF patients to start in 4Q 2023 (The LEVEL Study)

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November 27, 2023 — Tenax Therapeutics, Inc., a specialty pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, announced 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 Northwestern University Feinberg School of Medicine, and Chair of the LEVEL Steering Committee. “I am pleased to be leading this important new trial investigating TNX-103, which is designed to help advance our understanding of how K+ATP activation may provide a new approach for reducing the high central and venous blood pressures frequently associated with PH-HFpEF.” 

“Based on its unique properties as a K+ ATP channel activator, coupled with the proof-of-concept data from the Phase 2 HELP study, TNX-103 has mechanistic potential to address the underlying pathophysiology of PH-HFpEF,” said Stuart Rich, M.D., Chief Medical Officer of Tenax Therapeutics. “We expect oral levosimendan will provide consistent drug concentration levels, supporting improved efficacy, as observed in patients who transitioned from weekly IV to oral therapy following the HELP study.”            

Tenax Therapeutics and its CRO partner have already selected more than two-thirds of the research sites targeted to participate in the LEVEL Study, including many of the leading cardiovascular centers in the United States and Canada. Every investigative site that enrolled patients in the HELP Study has been invited to participate in LEVEL, and already 90% have agreed to take part.   

For more information: www.tenaxthera.com


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