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May 31, 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 it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for its patent application with claims covering the use of TNX-103, oral levosimendan, titled: “LEVOSIMENDAN FOR TREATING PULMONARY HYPERTENSION WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION (PH-HFpEF).”
The patent, once granted, will have a patent term through December 2040. It will provide the Company with substantial added intellectual property (IP) protection in the United States; Tenax will now have secured IP rights surrounding the use of oral, subcutaneous, and intravenous (IV) administration of levosimendan for the treatment of PH-HFpEF.
“With this Notice of Allowance, Tenax is now exceptionally well-positioned to realize the significant commercial potential of oral levosimendan, based on this new IP protection that will last until at least the end of 2040. Advancing this daily, oral formulation into Phase 3 studies for the treatment of PH-HFpEF, a heart condition affecting millions of people in the United States with no FDA approved treatments, is our next step,” said Chris Giordano, Chief Executive Officer of Tenax Therapeutics.
“I would like to thank my Tenax colleagues and our outside IP counsel who, over the course of several years, worked so diligently to help secure our levosimendan IP estate. Today’s announcement represents a major milestone for our Company in our mission to grow shareholder value by addressing a major unmet medical need in cardiovascular medicine, and with these foundational IP rights now in place, we look forward to updating shareholders on our progress as oral levosimendan advances into Phase 3 testing.”
Dr. Stuart Rich, Chief Medical Officer of Tenax Therapeutics, stated, “Based on its unique mechanistic properties as both a potassium ATP channel activator and calcium sensitizer, we believe oral levosimendan has a unique opportunity to become the first therapy ever approved for the treatment of PH-HFpEF, the most common type of PH globally. As demonstrated in the Phase 2 HELP Study, intravenous levosimendan is the only drug to have shown a significant improvement in exercise capacity for this patient population. Importantly, we have also received guidance from the FDA that the same 6-minute walking test used in the Phase 2 HELP Study can serve as the primary endpoint in our Phase 3 program.”
The patent covering the use of oral levosimendan for the treatment of PH-HFpEF is based on key discoveries from the HELP Study, in which levosimendan-treated PH-HFpEF patients benefited from a statistically significant improvement in 6-minute walk distance of 29 meters (p=0.03) when compared with placebo. When transitioning to the oral daily formulation after a lengthy treatment with the weekly IV formulation, the 6-minute walk results improved further.
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 60 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 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
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