Tenax Therapeutics Prioritizes Phase III Development of Pulmonary Hypertension Asset
By Alex Keown
April 12, 2023
Tenax Therapeutics will prioritize the clinical development of an oral levosimendan therapeutic for treatment of pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF), a disease that impacts more than 1.6 million people in North America.
Chapel Hill-based Tenax intends to initiate a Phase III study of TNX-103 (oral levosimendan) later this year. Tenax will prioritize levosimendan for PH-HFpEF over another experimental asset, imatinib, which the company has been developing for pulmonary arterial hypertension. The company made the decision based on multiple factors, including what it called a “significant market opportunity to develop the first FDA-approved therapy to address the millions of patients who suffer from this pervasive cardiovascular condition.” The company made the decision to prioritize TNX-103 following a strategic review that was initiated in September 2022.
Levosimendan is a unique potassium ATP channel activator and calcium sensitizer. The medication is designed to affect the heart and vascular system through multiple mechanisms of action.
Data from Tenax’s Phase II trial of levosimendan in patients with PH-HFpEF demonstrated that intravenous levosimendan produces “potent dilation of the central and pulmonary venous circulations.” That resulted in an improvement in exercise capacity. The data will form the basis of the Phase III trial, the company said.
Depending on trial design, a Phase III trial, or trials, of levosimendan could include multiple endpoints, including change in 6-minute walk distance over 12 weeks or clinical worsening of disease, such as death or hospitalization for heart failure, over a 24 week period. Following an end-of-Phase II meeting with the FDA, the regulatory agency agreed to replace weekly intravenous levosimendan dosing with daily TNX-103 doses in a Phase III clinical study, the company noted.
Tenax Chief Medical Officer Stuart Rich noted that although the pathophysiology of PH-HFpEF is not fully understood, it is known that “levosimendan is the only medicine to show an improvement in six-minute walk distance in this specific patient population.” Rich said the company’s experimental drug has the potential to address an underserved population of patients suffering from PH-HFpEF, which has a five year mortality rate of more than 50%.
The company estimates that by 2030, more than 2 million people in North America could be diagnosed with PH-HFpEF. Currently, there are no FDA approved drugs for this indication. Tenax Therapeutics aims to be first to market with levosimendan.
Outside the United States, intravenous levosimendan is approved for use in more than 60 countries as a treatment for in hospitalized patients with acutely decompensated heart failure. Tenax Therapeutics has North American rights to multiple formulations of levosimendan, including intravenous, subcutaneous and oral.
In order to preserve its planned market share, Tenax has strengthened its intellectual property claims around the drug. In March 2023, Tenax expanded its IP with patents covering the use of levosimendan to treat PH-HFpEF. Those patents could provide market protection for levosimendan until 2040, the company announced. That was the second levosimendan patent the company secured since early 2022. A potential third patent for an oral formulation of levosimendan could be granted this year.
Chris Giordano, chief executive officer of Tenax Therapeutics, noted the levosimendan IP expansion was a key objective for the company.
“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,” Giordano said in a statement. “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.”
The decision to prioritize development of levosimendan will push a Phase III study of imatinib outside of 2023, the company announced. That could change depending on available finances and other strategic considerations, the company said.
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Alex Keown is a freelance journalist who writes about a variety of subjects including the pharma, biotech, and life science industries. Prior to freelancing, Alex has served as a staff writer and editor for several publications.
