MORRISVILLE, N.C.--(BUSINESS WIRE)--Tenax Therapeutics, Inc. (NASDAQ: TENX) today announced the results of a new study titled "Differential Effects of Levosimendan and Dobutamine on Glomerular Filtration Rate in Patients With Heart Failure and Renal Impairment: A Randomized Double‐Blind Controlled Trial” were published in the August 21, 2018 issue of the Journal of the American Heart Association (https://www.ahajournals.org/doi/full/10.1161/JAHA.117.008455). The results indicate that levosimendan offers unique renal protective benefits to patients who have heart failure and coexisting impairment of their kidney function.
The study authors (Lannemyr, et al) note “this study is the first evaluating the differential effects of levosimendan and a catecholamine on measured RBF, GFR, and renal oxygenation in patients with HF and renal dysfunction.” Renal impairment is a common comorbidity seen in HF patients and is a strong predictor of their mortality. This study provides evidence of a mechanistic explanation for direct renal protective effects that is based on the unique K-ATP channel mechanism of levosimendan. The findings of this study are consistent with previous studies that provide evidence that levosimendan improves GFR and other metrics of renal function in heart failure patients. These facts contributed to the authors’ conclusion that levosimendan may be a preferred drug for heart failure patient with impaired renal function.
The study enrolled 32 patients with HF and renal impairment in a randomized, double-blind, controlled design and compared the acute renal and systemic effects of moderate doses of levosimendan (0.1 µg/kg per minute) and dobutamine (7.5µg/kg per minute). Both agents induced a renal vasodilation and increased RBF to a similar extent. However, only levosimendan treated patients experienced an increase in GFR (22%, P=0.012). In contrast, dobutamine treated patients experienced no improvement in GFR.
Anthony DiTonno, CEO of Tenax Therapeutics, stated “The results of this new study are encouraging. These findings are consistent with earlier studies and potentially very relevant to our current levosimendan clinical development plans in heart failure patients with pulmonary hypertension and preserved ejection fraction (PH-HFpEF). Heart failure patients commonly suffer from renal dysfunction and should benefit from the unique renal protective benefits that levosimendan appears to provide heart failure patients, including PH-HFpEF patients with renal impairment.”
About Tenax Therapeutics
Tenax Therapeutics, Inc., is a specialty pharmaceutical company focused on identifying, developing and commercializing products for the critical care market. 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 in the start-up stage of a 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 2, 2018, its quarterly report on Form 10-Q filed on August 14, 2018 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.