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July 26, 2023 — Tenax Therapeutics, Inc, a specialty pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, announced that the United States Patent and Trademark Office (USPTO) has granted a new method of use patent for oral levosimendan (TNX-103) in the treatment of pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF), expiring in 2040.
The issued patent (U.S. Patent No. 11,701,355) covers the use of oral levosimendan for the treatment of PH-HFpEF and provides exclusivity through December 2040. The ‘355 patent further builds upon the Company’s substantial IP, which also includes issued U.S. patents for the use of intravenous (U.S. Patent No. 11,607,412) and subcutaneous (U.S. Patent No. 11,213,524) formulations of levosimendan for the treatment of PH-HFpEF.
"The issuance of patent ‘355 is a very important achievement in protecting the discoveries made with the HELP Study, while also preserving for our shareholders the substantial commercial value of potentially developing the first drug to treat this large and underserved patient population,” said Chris Giordano, Chief Executive Officer of Tenax Therapeutics. “With this patent now in hand, providing us a potential commercial runway to December 2040, we are excited to be moving into Phase 3 testing with the oral formulation, where we hope to demonstrate the ability of TNX-103 to address this significant unmet need in patients with PH-HFpEF.”
Stuart Rich MD, Chief Medical Officer of Tenax Therapeutics commented, “The advancement of TNX-103 represents a transformative opportunity to establish a treatment for patients with PH-HFpEF. This is the most commonly seen patient in pulmonary hypertension referral centers, and yet not a single therapy has been approved for them. Finally, the unmet need of these patients may now be addressed.”
Tenax Therapeutics is actively engaged with its Scientific Advisory Board, the FDA, and a CRO partner regarding the execution of a Phase 3 trial of TNX-103, planned to commence in 2023.
About Levosimendan (TNX-101, TNX-102, and TNX-103)
Levosimendan is a unique potassium ATP channel activator and calcium sensitizer that affects the heart and vascular system through multiple mechanisms of action. Initially discovered and developed by Orion Corporation in Finland, intravenous levosimendan is approved in over 58 countries outside the United States for use in hospitalized patients with acutely decompensated heart failure. Tenax Therapeutics has North American rights to develop and commercialize IV (TNX-101), subcutaneous (TNX-102), and oral (TNX-103) formulations of levosimendan. Results of Tenax Therapeutics’ Phase 2 HELP trial of levosimendan in patients with pulmonary hypertension (PH) and heart failure with preserved ejection fraction (HFpEF) demonstrated that IV levosimendan produces potent dilation of the central and pulmonary venous circulations which translates into an improvement in exercise capacity, a discovery that forms the basis for the Phase 3 investigation of Tenax Therapeutics’ potential groundbreaking therapy. To date, no other drug therapy has improved exercise tolerance in patients with PH associated with HFpEF, “a growing epidemic with high morbidity and mortality and no treatment. The clear unmet need and lethal nature of PH-HFpEF must be met with novel solutions at all levels of therapeutic development.” (AHA Scientific Advisory, “A Call to Action,” 2022).
About Imatinib (TNX-201)
Tenax Therapeutics is developing novel dosing and a unique formulation of imatinib mesylate, a kinase inhibitor that has received FDA’s orphan designation (March 2020) for the treatment of pulmonary arterial hypertension (PAH). The IMPRES trial, a previous Phase 3 trial, demonstrated that oral imatinib may produce a markedly greater, and much more durable, treatment effect on exercise tolerance, than any other available PAH treatment, alone or in combination, based on the results observed in those patients who were maintained on the full imatinib dose for the majority of the trial. Despite the availability of several classes of pulmonary vasodilators, no existing treatment has been shown to halt progression or induce regression of the disease. Imatinib acts on underlying cellular proliferative pathways associated with PAH and has the potential to be approved as a disease modifying therapy for PAH.
For more information: www.tenaxthera.com
April 16, 2024 
