MORRISVILLE, N.C.--(BUSINESS WIRE)--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, today provided an update on its on-going clinical trial of levosimendan.
Clinical Development Update
Tenax is conducting a multi-center, double-blind placebo controlled Phase 2 trial designed to evaluate levosimendan in patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF). The study is also known as the HELP Trial (Hemodynamic Evaluation of Levosimendan in Patients with PH-HFpEF). There are currently 12 activated sites, with an additional three sites expected to be activated over the next few weeks, which we believe will be sufficient to fully enroll the trial. Eight patients, up from three at the end of June, are currently enrolled out of the targeted 36 patients. Three of the eight patients have completed the initial 6-week HELP protocol and have rolled over into the 2-year extension phase
Anthony DiTonno, CEO of Tenax Therapeutics, commented, “We are pleased with the progress made over the past few months to advancing the Phase 2 trial. Based on feedback from our principal investigators we have modified and adapted our protocols for the HELP trial. These modifications, in addition to achieving our targeted number of clinical sites, have resulted in an acceleration in the pace of patient enrollment. Given the momentum in the quarter, we now expect full enrollment and top-line data in the HELP Trial in the first quarter of 2020. We are also pleased to announce that the company has developed and recently filed a patent application for a subcutaneous formulation of levosimendan. Future development activities will be finalized following the completion of our phase 2 HELP trial and subsequent discussion with the FDA on a phase 3 trial for PH-HFpEF patients.”
About Tenax Therapeutics
Tenax Therapeutics, Inc., is a specialty pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases 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 currently enrolling 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). 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, 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; the impact of management changes on the Company’s business and unanticipated charges, costs and expenditures not currently contemplated that may occur as a result of management changes; 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 1, 2019, its quarterly report on Form 10-Q filed on August 14, 2019 as well as 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.