- Company to prioritize the clinical development of TNX-103 (oral levosimendan) for the treatment of pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF)
- PH-HFpEF affects more than 1,600,000 North Americans, with estimates indicating a prevalence of more than 2,000,000 patients by 2030
- Strategic decision based upon this significant unmet medical need, no FDA-approved therapies, and an expanding patent estate covering the use of levosimendan to treat PH-HFpEF which could provide protection in the U.S. until at least 2040
- Company expects to initiate a Phase 3 trial of oral levosimendan in PH-HFpEF in 2023
CHAPEL HILL, N.C., April 12, 2023 (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 provided a business update outlining the Company’s product development plans for 2023.
Based on a strategic review process which began in September 2022, the Company has decided to prioritize the Phase 3 testing of TNX-103 (oral levosimendan), with plans to commence a levosimendan Phase 3 study in 2023. The decision to prioritize the clinical development of TNX-103 ahead of imatinib is based on several factors, including a growing intellectual property estate that encompasses the use of levosimendan to treat PH-HFpEF in the United States, along with the significant market opportunity to develop the first FDA-approved therapy to address the millions of patients who suffer from this pervasive cardiovascular condition.
“Expanding our IP estate to include multiple formulations of levosimendan for use in the treatment of PH-HFpEF remains a key strategic objective for our company,” said Chris Giordano, Tenax Therapeutics’ Chief Executive Officer. “Our team has worked diligently to help ensure that levosimendan will have patent protections surrounding its use to treat patients with PH-HFpEF until at least 2040, and we anticipate receiving additional IP protection in 2023 to further expand this estate. By prioritizing the development of the oral formulation, we intend to provide patients a daily, oral strategy to maintain therapeutic levels of levosimendan, and maximize the commercial potential of this unique, promising drug. We are embarking on a cost-effective, efficient pathway to significant shareholder value.”
In March, the United States Patent and Trademark Office (USPTO) granted Tenax a patent that covers the use of intravenous (IV) levosimendan in patients with PH-HFpEF. This is the second levosimendan patent granted to the Company since early 2022, and provides a strong basis for a potentially successful review of a third patent that will specifically cover claims related to TNX-103 (oral levosimendan), which could be granted in 2023.
The impetus for expanding levosimendan’s intellectual property is largely derived from the positive clinical data and observations from the landmark HELP Study, including the innovative weekly 24-hour IV dosing, unique home-based site of administration, the transition from IV to oral therapy in a subset of patients (who continued in the OLE until the commencement of the transition sub study), and the novel findings of efficacy and safety in PH-HFpEF patients – all representing important discoveries and significant intellectual property. These discoveries, among others from the HELP Study, form the basis for U.S. patent applications Tenax has filed.
“Considering the therapeutic advancements that have been made across most areas of cardiovascular medicine over the last several decades, it is remarkable that, despite the millions of patients suffering with PH-HFpEF, not a single medication has been approved to treat this highly debilitating and life-threatening condition,” said Dr. Stuart Rich, Chief Medical Officer of Tenax Therapeutics. “While the pathophysiology of PH-HFpEF is not fully understood, we do know that levosimendan is the only medicine to show an improvement in six-minute walk distance in this specific patient population. We believe levosimendan has the potential to address this significant and underserved patient population, and we look forward to advancing this promising therapy into Phase 3 testing later this year.”
Clinical Development Pathway for Levosimendan in PH-HFpEF
Based on an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), the FDA agreed that one or two Phase 3 clinical studies (depending on the size) with a primary endpoint of change in 6-minute walk distance over 12 weeks, or a single Phase 3 trial with clinical worsening (e.g., death, hospitalization for heart failure, or decline in exercise capacity) over 24 weeks would be sufficient to demonstrate the effectiveness of levosimendan in PH-HFpEF. The FDA also agreed to a plan to replace weekly intravenous levosimendan dosing with daily TNX-103 (oral) doses in a Phase 3 clinical study.
Based on data from the Company’s Phase 2 study and open-label extension, levosimendan was able to demonstrate its effect on relaxing the venous circulation – an underappreciated mechanistic feature of the drug that is thought to result in durable improvements in exercise capacity and quality of life, as well as other clinical assessments, in patients with PH-HFpEF. FDA has approved no pharmaceutical therapies for the treatment of PH-HFpEF.
With respect to imatinib, the decision to prioritize the Phase 3 testing of levosimendan places the start of a Phase 3 imatinib trial likely outside the 2023 timeframe, pending fundraising to support that trial, as well as other strategic considerations.
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, recently referred to as the greatest unmet need in cardiovascular disease.
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.
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 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 of the statements, expectations and assumptions contained in this press release are forward-looking statements. 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 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; 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 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 evolving COVID-19 pandemic 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.
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