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Tenax Therapeutics Enrolls First Patient in Phase 3 LEVEL Study Evaluating TNX-103 (Oral Levosimendan) for the Treatment of Pulmonary Hypertension in Heart Failure with Preserved Ejection Fraction (PH-HFpEF)

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Tenax Therapeutics, Inc. has announced the enrollment of the first patient in the Phase 3 LEVEL Study, a trial for the treatment of pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF). The study will involve 152 patients and is expected to produce topline data by the second half of 2025. The company has highlighted the reduced costs and time for the registration of TNX-103 due to the FDA not requiring a long-term cardiovascular outcomes trial, and the extensive patent estate for levosimendan until at least 2040.
Positive
  • Enrollment of the first patient in the Phase 3 LEVEL Study
  • Participation of prestigious cardiovascular research institutes in North America
  • Reduced costs and time for the registration of TNX-103 due to FDA's requirements
  • Extensive patent estate for levosimendan until at least 2040
Negative
  • Topline data from the LEVEL study not available until the second half of 2025
  • The Phase 3 program for TNX-103 requires a large number of patients for drug exposure

The initiation of the Phase 3 LEVEL study by Tenax Therapeutics marks a significant advancement in the pursuit of treatment options for PH-HFpEF, a subset of heart failure patients characterized by pulmonary hypertension and preserved ejection fraction. The current lack of FDA-approved drugs for this condition underscores the potential impact of TNX-103, an oral formulation of levosimendan. The focus on six-minute walking distance (6MWD) as the primary endpoint is a clinically relevant measure of exercise capacity, which is often severely limited in PH-HFpEF patients.

Levosimendan, traditionally used intravenously for acute decompensated heart failure, has a unique mechanism of action, enhancing myocardial contractility without increasing myocardial oxygen demand. This dual action as a calcium sensitizer and potassium channel opener could provide symptomatic relief and potentially improve outcomes in PH-HFpEF, a condition where many patients remain symptomatic despite optimal medical management. The selection of prominent research centers for the LEVEL study not only facilitates patient recruitment but also lends credibility to the research, given the investigators' expertise in cardiovascular diseases.

The extensive patent estate surrounding levosimendan, as highlighted by Tenax Therapeutics, is crucial in understanding the commercial strategy for TNX-103. With protections extending to at least 2040, Tenax has a significant window to recoup research and development costs and maximize profits should TNX-103 gain FDA approval. The mention of strategic partners indicates Tenax's openness to collaborations that could expedite commercialization efforts and expand market reach.

Furthermore, the patent coverage not only for the oral formulation but also for intravenous and subcutaneous routes offers flexibility in addressing different patient needs and clinical settings. The potential for TNX-103 to become a first-in-class therapy for PH-HFpEF would give Tenax a competitive edge in the market, especially considering the high unmet medical need in this patient population.

From a market perspective, the progression of TNX-103 through clinical trials is likely to be closely monitored by investors and industry stakeholders. The targeted patient population, PH-HFpEF, represents a niche yet significant market due to the high unmet medical need and the lack of specific treatments. The successful completion of the LEVEL study and subsequent FDA approval could lead to a substantial market share for Tenax Therapeutics.

The strategic decision by Tenax to conduct a Phase 3 trial without the need for a long-term cardiovascular outcomes trial, as per FDA guidance, may reduce both development costs and time to market. This could result in a faster return on investment and a more attractive financial profile for the company. However, it is important to note that clinical trials are inherently risky and positive outcomes are not guaranteed. The anticipated availability of topline data in the second half of 2025 means that any potential market impact will not be immediate, but rather a mid-term prospect for the company and its investors.

Over 40 sites (U.S. and Canada) have agreed to participate in the LEVEL study

LEVEL is a randomized, controlled Phase 3 trial of 152 patients, and will recruit patients primarily from leading research centers with large PH-HFpEF populations

Tenax forecasts topline LEVEL data will be available second half of 2025

CHAPEL HILL, N.C., Feb. 07, 2024 (GLOBE NEWSWIRE) -- Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, today announced that the first patient has enrolled in the Company’s Phase 3 LEVEL Study (LEVosimendan to Improve Exercise Limitation in PH-HFpEF Patients) (NCT05983250).

“We are pleased to announce the enrollment of our first patient in the Phase 3 LEVEL study, and delighted we are progressing rapidly from identification to initiation of investigator sites,” said Chris Giordano, President and Chief Executive Officer of Tenax Therapeutics. “The Tenax team and our CRO and other research partners have worked tirelessly to reach this milestone. Our study is generating enthusiasm among North American cardiologists who treat PH-HFpEF. FDA has approved no drugs, to date, for this disease.”

As previously disclosed, the FDA does not require Tenax conduct a long-term, cardiovascular outcomes trial in this population, significantly reducing the costs and time for the registration of TNX-103. The extensive levosimendan patent estate includes protections through at least 2040 of all therapeutic doses of the proprietary oral formulation (TNX-103) being evaluated in LEVEL, as well as I.V. and subcutaneous formulations, in patients with PH-HFpEF. We believe this positions Tenax, and potential strategic partners, to maximize the commercial potential of this unique, first-in-class therapy.   

“We are thrilled to be working with some of the largest, most prestigious cardiovascular research institutes in North America, if not the world,” said Stuart Rich, M.D., Chief Medical Officer of Tenax Therapeutics. “Nine of the ten investigators who randomized patients in our previous levosimendan study – at sites like Mayo, Harvard, Northwestern – have agreed to enroll patients in LEVEL. This reflects a growing interest among these academic medical experts in the novel mechanism of action of levosimendan, and a new approach to this disease.”

The LEVEL study is the first of two planned Phase 3 studies that will evaluate TNX-103 (oral levosimendan) for the treatment of pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF). The LEVEL study will evaluate six-minute walking distance (6MWD) as the primary endpoint, and will enroll a total of 152 patients. The Phase 3 program for TNX-103 has been designed to exceed the minimal clinically important difference, and satisfy the U.S. Food and Drug Administration’s request for subject drug exposure of 300 patients for 6 months and 100 patients for 1 year (these are minimum requirements per ICH guidelines).

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 or placebo 2 mg/day for Weeks 1 to 4 and 3 mg/day for Weeks 5 to 12. The primary outcome measure for the study is 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 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 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 specialty pharmaceutical company focused on identifying, developing, and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need. The Company owns North American rights to develop and commercialize IV, subcutaneous, and oral formulations of levosimendan. Tenax Therapeutics also is developing a unique oral formulation of imatinib.  For more information, visit www.tenaxthera.com. Tenax’s common stock is listed on The Nasdaq Stock Market LLC under the symbol “TENX”.

Caution Regarding Forward-Looking Statements

Except for historical information, all 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: risks related to our business strategy, including the prioritization and development of product candidates; risks of our clinical trials, including, but not limited to, the timing, delays, costs, design, initiation, continued 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; our ability to raise additional money to fund our operations for at least the next 12 months as a going concern; intellectual property risks; 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 COVID-19 pandemic or similar health epidemics and geopolitical uncertainties such as in 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


The LEVEL study is a Phase 3 trial for evaluating TNX-103 (oral levosimendan) for the treatment of pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF).

The topline data from the LEVEL study is expected to be available in the second half of 2025.

The primary endpoint of the LEVEL study is the six-minute walking distance (6MWD).

The reduced costs and time for the registration of TNX-103 are due to the FDA not requiring a long-term, cardiovascular outcomes trial in this population.

The extensive levosimendan patent estate includes protections through at least 2040 of all therapeutic doses of the proprietary oral formulation (TNX-103) being evaluated in LEVEL, as well as I.V. and subcutaneous formulations, in patients with PH-HFpEF.
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tenax therapeutics is focused on developing and commercializing pharmaceutical products that improve outcomes for patients who require treatment for various critical care conditions. our development portfolio includes novel product candidates that have the potential to address various critical care conditions with high unmet medical need.