Tenax Therapeutics Announces New U.S. Patent Covering the Use of Levosimendan in Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF)

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Tenax Therapeutics, Inc. announced a new U.S. patent covering the use of levosimendan in Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF) until December 2040. The patent broadens protection for oral, IV, and subcutaneous use of levosimendan, and its active metabolites, also allowing for additional U.S. patent term extension. This patent is the third granted to Tenax since March 2023, protecting the use of levosimendan in treating PH-HFpEF.

Positive

• New U.S. patent (No. 11,969,424) expands IP protection for Tenax Therapeutics' leveraged for use in PH-HFpEF until December 2040.

• The patent covers oral, IV, and subcutaneous administration of levosimendan, as well as its active metabolites, for the treatment of PH-HFpEF at all therapeutic doses.

• Additional IP protection for the use of levosimendan in combination with various cardiovascular drugs in PH-HFpEF patients is provided, enhancing the potential treatment options.

Negative

• The HELP Study results showing a statistically significant improvement in exercise performance in PH-HFpEF patients may not be replicated in real-world settings, leading to potential clinical discrepancies.

Pharmaceutical Patent Analyst

The granting of a new patent for levosimendan in the treatment of PH-HFpEF to Tenax Therapeutics significantly extends the intellectual property runway, allowing the company exclusive rights to commercialize its formulations until 2040, with potential for further extension. This extensive period of exclusivity underlines the substantial investment in R&D by Tenax and serves to protect its market position against generic competition. The patent also encompasses various administration methods and combination therapies, which can be pivotal in differentiating Tenax's product in a competitive pharmaceutical landscape. Diversification of administration routes offers flexibility in treatment regimens, potentially improving patient compliance and outcomes. Furthermore, the solid results from the HELP Study, which underpin this patent, lend credence to levosimendan's efficacy. This could translate into a competitive edge in a market where payers and clinicians are increasingly outcome-focused. Tenax's portfolio expansion through this patent is likely to appeal to investors, as it suggests a long-term revenue stream contingent upon successful commercialization and adoption of the therapy.

Cardiovascular Medical Research Analyst

Heart failure with preserved ejection fraction (PH-HFpEF) is a challenging clinical condition with limited treatment options, which makes the development of levosimendan noteworthy from a medical standpoint. The noteworthy 29-meter improvement in the 6-minute walk test signifies not just statistical, but also potential clinical relevance. This test is a widely recognized measure of functional status in heart failure patients and improvements can correlate with better quality of life. Looking ahead, the ongoing Phase 3 LEVEL study's focus on oral levosimendan speaks to ease of use and patient adherence, two nontrivial concerns in chronic disease management. Levosimendan's proactive patent protection strategy aligns with the industry's move towards value-based healthcare, where reimbursement is increasingly tied to patient outcomes. For retail investors, the implications of these developments are twofold: they represent both a potentially significant advancement in heart failure treatment and also a strategic commercial maneuver that could translate to a robust positioning for Tenax in the cardiovascular market.

• Broadens IP protection for oral (TNX-103), IV, and subcutaneous use of levosimendan, and its active metabolites (OR1896 and OR1855), in PH-HFpEF
• Provides U.S. intellectual property (IP) protection until December 2040, and may qualify for additional U.S. patent term extension (PTE) beyond 2040
• Expressly provides IP protection for levosimendan at all therapeutic doses for use in PH-HFpEF
• Expressly provides IP protection for levosimendan in combination with various cardiovascular drugs for use in PH-HFpEF
• Represents the third patent granted to Tenax since March of 2023 protecting the use of levosimendan in the treatment of PH-HFpEF
  

CHAPEL HILL, N.C., April 30, 2024 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX), a Phase 3, development-stage pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, announced today that the United States Patent and Trademark Office (USPTO) has granted the Company a patent covering the use of TNX-103 (oral levosimendan), TNX-102 (subcutaneous levosimendan), TNX-101 (IV levosimendan), the active metabolites of levosimendan (OR1896 and OR18955) and various combinations of cardiovascular drugs with levosimendan when used to improve exercise performance in PH-HFpEF patients, entitled: “LEVOSIMENDAN FOR TREATING PULMONARY HYPERTENSION WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION (PH-HFpEF).”

“Expanding our intellectual property estate for levosimendan is a strategic priority for Tenax. We are committed to protecting the future commercial value of our innovative PH-HFpEF treatment,” said Chris Giordano, President & Chief Executive Officer of Tenax Therapeutics. “The important, additional IP protection this patent provides will help us maximize the value of levosimendan as we seek to address one of the largest unmet needs in cardiovascular medicine today.”

This newly issued patent, U.S. Patent No. 11,969,424, provides protections through December 2040, including expanded IP rights to the use of oral, subcutaneous, and intravenous (IV) administration of levosimendan, as well as its active metabolites (OR1896 and OR1855) for the treatment of PH-HFpEF, at all therapeutic doses. The patent also provides IP protection for the use of combinations with various cardiovascular drugs, when used in PH-HFpEF patients.

The patents covering the use of IV and oral levosimendan for the treatment of PH-HFpEF rely on key discoveries Tenax Therapeutics made with 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 IV levosimendan was compared with placebo. Patients who transitioned to the oral daily formulation after a lengthy treatment with the weekly IV formulation improved further in this assessment of exercise tolerance, which is the primary endpoint of the ongoing Phase 3 LEVEL study.

About the Phase 3 LEVEL Study ( NCT05983250 )

The LEVEL Study is a Phase 3, double-blind, randomized, placebo-controlled study of levosimendan in patients with PH-HFpEF. Approximately 152 subjects will be randomized in a 1:1 ratio to receive an oral dose of levosimendan (2 mg/day) or placebo for Weeks 1 to 4 and 3 mg/day or placebo for Weeks 5 to 12. The primary outcome measure for the study is change in six-minute walk distance from Baseline to Week 12. All randomized subjects will have the option to enter the 92-week OLE following the completion of all study events at Week 12.

About Levosimendan (TNX-101, TNX-102, 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 60 countries outside the United States for use in hospitalized patients with acutely decompensated heart failure. Results of Tenax Therapeutics’ Phase 2 HELP study of levosimendan in patients with pulmonary hypertension (PH) with heart failure with preserved ejection fraction (HFpEF) demonstrated that I.V. levosimendan produces potent dilation of the central and pulmonary venous circulations which translates into an improvement in exercise capacity, a discovery that is the basis of LEVEL, 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 Tenax Therapeutics

Tenax Therapeutics, Inc. is a Phase 3, development-stage pharmaceutical company focused on identifying, developing, and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need. The Company owns global rights to develop and commercialize levosimendan, which it has prioritized in the near term. Tenax Therapeutics also may resume developing its unique oral formulation of imatinib. For more information, visit www.tenaxthera.com. Tenax Therapeutics’ common stock is listed on The Nasdaq Stock Market LLC under the symbol “TENX”.

Caution Regarding Forward-Looking Statements

Except for historical information, all of the statements, expectations and assumptions contained in this press release are forward-looking statements. These forward-looking statements may include information concerning possible or projected future business operations. Actual results might differ materially from those explicit or implicit in the forward-looking statements. Important factors that could cause actual results to differ materially include: our ability to raise additional money to fund our operations for at least the next 12 months as a going concern; risks related to our business strategy, including the prioritization and development of product candidates; intellectual property risks; risks of our clinical trials, including, but not limited to, the timing, delays, costs, design, initiation, enrollment, and results of such trials; any delays in regulatory review and approval of product candidates in development; reliance on third parties, including Orion Corporation, our manufacturers and CROs; risks regarding the formulation, production, marketing, customer acceptance and clinical utility of our product candidates; our estimates regarding the potential market opportunity for our product candidates; the potential advantages of our product candidates; our competitive position; risks related to our continued listing on Nasdaq; our ability to maintain our culture and recruit, integrate and retain qualified personnel and advisors, including on our Board of Directors; volatility and uncertainty in the global economy and financial markets in light of the possibility of pandemics, global financial and geopolitical uncertainties, including in the Middle East and the Russian invasion of and war against the country of Ukraine; changes in legal, regulatory and legislative environments in the markets in which we operate and the impact of these changes on our ability to obtain regulatory approval for our products; and other risks and uncertainties set forth from time to time in our SEC filings. Tenax Therapeutics assumes no obligation and does not intend to update these forward-looking statements except as required by law.

Contacts:

Investor Contact:
John Fraunces
Managing Director
LifeSci Advisors, LLC
C: 917-355-2395, or

Brian Mullen
LifeSci Advisors, LLC
C: 203-461-1175

FAQ

What is the new U.S. patent for Tenax Therapeutics regarding levosimendan?

Tenax Therapeutics announced a new U.S. patent (No. 11,969,424) covering the use of levosimendan in Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF) until December 2040.

What does the new patent protect regarding levosimendan administration?

The patent provides expanded IP protection for oral, IV, and subcutaneous use of levosimendan, and its active metabolites, for the treatment of PH-HFpEF at all therapeutic doses.

Is there additional IP protection for the use of levosimendan in combination with other drugs in PH-HFpEF patients?

Yes, the patent also covers the use of levosimendan in combination with various cardiovascular drugs for the treatment of PH-HFpEF, enhancing the potential treatment options.