MORRISVILLE, N.C.--(BUSINESS WIRE)--Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty pharmaceutical company focused on providing products to address conditions with significant unmet medical needs, today announced 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.”
About Tenax Therapeutics
Tenax Therapeutics, Inc., is a specialty pharmaceutical company focused on licensing, development, and commercialization of drugs that address conditions with high unmet medical need. The Company has a world-class scientific team including recognized global experts in pulmonary hypertension. The Company owns the North American rights to develop and commercialize levosimendan and is finalizing preparations to begin their Phase 2 clinical trial for the use of levosimendan in the treatment of Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF) early in the second half of 2018. For more information, visit www.tenaxthera.com.
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, Orion Corporation of Espoo Finland, 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.
Caution Regarding Forward-Looking Statements
This news release contains certain forward-looking statements by the company that involve risks and uncertainties and reflect the Company’s judgment as of the date of this release. The forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to matters beyond the Company’s control that could lead to delays in the clinical study, delays in new product introductions and customer acceptance of these new products, matters beyond the Company’s control that could impact the Company’s continued compliance with Nasdaq listing requirements, and other risks and uncertainties as described in the Company’s filings with the Securities and Exchange Commission, including in its annual report on Form 10-K filed on April 2, 2018 and its other filings with the SEC. The Company disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. Statements in this press release regarding management’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.