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84% of PH-HFpEF patients responded to levosimendan based on prespecified criteria in the initial open-label lead-in phase
Levosimendan improved cardiovascular hemodynamics and exercise capacity in PH-HFpEF patients
Levosimendan produced a significant improvement in 6-minute walk distance and is the only therapy to produce such a result in a randomized, double-blind, placebo-controlled trial of PH-HFpEF patients
Levosimendan was well tolerated in PH-HFpEF patients
Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty pharmaceutical company focused on identifying and developing therapeutics that address cardio-pulmonary diseases with high unmet medical need, today announced the publication of positive data from the company’s Phase 2 HELP Study that evaluated levosimendan in patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF). The new publication is titled Levosimendan Improves Hemodynamics and Exercise Tolerance in PH-HFpEF: Results of the Placebo-Controlled HELP Trial and was published in the Journal of American College of Cardiology: Heart Failure (https://www.jacc.org/doi/pdf/10.1016/j.jchf.2021.01.015).
The HELP (Hemodynamic Evaluation of Levosimendan in PH-HFpEF) Study was designed as a randomized placebo-controlled trial to evaluate the hemodynamic and clinical effects of weekly levosimendan IV infusions in PH-HFpEF patients. This 6-week study design evaluated invasive cardiovascular hemodynamics as well as secondary clinical endpoints including a 6-minute walk test.
Results reported in the publication include an impressive responder rate of 84% during the open-label phase as 37 of 44 patients met responder criteria and were randomized to levosimendan (n=18) or placebo (n=19). Compared with placebo, levosimendan did not significantly reduce the primary endpoint of exercise-PCWP (-1.4 mmHg, 95% CI -7.8, 4.8, p=0.65), but effectively reduced PCWP measured across all exercise stages (-3.9±2.0 mmHg, p=0.047). Levosimendan treatment resulted in a 29.3 meter (95% CI [2.5, 56.1], p=0.033) improvement in 6 MWD compared to placebo. The authors concluded that further study of levosimendan in PH-HFpEF patients is warranted since levosimendan is the first drug to demonstrate improved cardiovascular hemodynamics and a statistically significant increase in six-minute walk distance seen compared to placebo
Dr. Daniel Burkhoff, MD PhD, Director of Heart Failure, Hemodynamics and Mechanical Circulatory Support Research at Cardiovascular Research Foundation led the blinded hemodynamic core lab and analysis for the HELP trial and is the first author on the publication. Dr. Burkhoff stated "The cardiovascular hemodynamic effects seen in this trial following levosimendan administration were impressive, especially in the first 24 hours. The reductions in cardiac filling pressures and associations with improved exercise performance are important early markers of clinical benefit and signify meaningful improvements in the wellbeing of PH-HFpEF patients. Levosimendan has the potential to have a major impact on the treatment of PH-HFpEF."
Dr. Stuart Rich, Chief Medical Officer at Tenax Therapeutics and Principal Investigator of the study stated "PH-HFpEF, which is Group 2 Pulmonary Hypertension, is a progressive and fatal disease with no effective medical treatments. Previous attempts to identify an effective treatment from clinical trials using approved pulmonary vasodilators have all failed. This is the first multi-center, randomized, placebo-controlled trial in PH-HFpEF patients to report a statistically significant improvement in 6-minute walk distance. Levosimendan has unique pulmonary vascular and cardiovascular properties which we identified as central to its clinical efficacy. The fact that 84% of the patients enrolled in the initial lead-in phase had a significant hemodynamic response at rest and with exercise during cardiac catheterization provides confidence that levosimendan may be an important treatment for these patients who have a large unmet need."
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 advisory team including recognized global experts in pulmonary hypertension. The Company owns North American rights to develop and commercialize levosimendan and has recently released topline data regarding 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). Tenax plans to advance a delayed release oral formulation of imatinib, designed to avoid the gastric irritation, into a single pivotal trial pursuant to the 505(b)(2) pathway. For more information, visit www.tenaxthera.com.
Levosimendan is a calcium sensitizer and K-ATP Channel activator that works through a unique 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 North American rights to develop and commercialize levosimendan from Phyxius Pharma, Inc.
Imatinib is an antiproliferative agent developed to target the BCR-ABL tyrosine kinase in patients with chronic myeloid leukemia. The inhibitory effects of imatinib on PDGF receptors and c-KIT suggested that it may be efficacious in PAH. Imatinib reversed experimentally induced pulmonary hypertension and has pulmonary vasodilatory effects in animal models and proapoptotic effects on pulmonary artery smooth muscle cells from patients with idiopathic PAH. In a phase 3 clinical trial imatinib produced significant improvements in exercise capacity, but a high rate of dropouts attributed largely to gastric intolerance prevented regulatory approval.
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 March 31, 2021 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.
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