FDA Says Tenax Therapeutics Can Submit Levosimendan Ph II Protocol for Pulmonary Hypertension Under Existing IND

April 5, 2018

Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty pharmaceutical company focused on providing products to address conditions with significant unmet medical needs, announced on 4/4/2018 the results of its pre-Investigational New Drug (pre-IND) meeting with the United States Food & Drug Administration (FDA), where the FDA addressed the company’s questions and provided guidance on its upcoming Phase 2 clinical trial in the use of levosimendan for treatment of Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF).

The FDA agreed that the new Phase 2 clinical protocol can be submitted under the existing IND, and supported the study design and endpoints for demonstrating proof-of-concept in PH-HFpEF patients.

“We are very pleased with the outcome of the pre IND meeting,” said Michael Jebsen, Interim CEO of Tenax. “The initial pathway to move forward with the development of levosimendan in PH-HFpEF has been clarified and confirmed. We will finalize our Phase 2 clinical trial protocol for IND submission and continue preparations for a late June or July start of the trial.”

Levosimendan is a calcium sensitizer that works through a unique triple mechanism of action. It initially was developed for intravenous use in hospitalized patients with acutely decompensated heart failure. It was discovered and developed by Orion Pharma, and is currently approved in over 60 countries for this indication and not available in the United States. Tenax Therapeutics acquired the North American rights to develop and commercialize levosimendan from Phyxius Pharma, Inc.

Clinical data from heart failure patients show that levosimendan improves haemodynamics without a significant increase in oxygen consumption. Levosimendan also has favorable effects on neurohormone levels in heart failure patients.

Tenax Therapeutics' website currently lists levosimendan as their only drug in development.

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