Tenax Therapeutics has received notification from the European Patent Office (EPO) of its intention to grant patent protection for the use of levosimendan in treating pulmonary hypertension resulting from heart failure with preserved ejection fraction (PH-HFpEF). The patent will provide intellectual property protection in Europe through December 2040 and may qualify for additional patent term extensions beyond that date.
The patent covers TNX-103, Tenax's oral formulation of levosimendan, along with other drug formulations and active metabolites for treating PH-HFpEF. According to Chris Giordano, President and Chief Executive Officer of Tenax Therapeutics, "This patent will protect our use of levosimendan in PH-HFpEF, including TNX-103, in Europe, where prevalence estimates indicate the number of patients currently suffering from this disease approximates the number estimated in North America."
Comprehensive Patent Coverage
The EPO patent application, titled "LEVOSIMENDAN FOR TREATING PULMONARY HYPERTENSION WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION (PH-HFpEF)," provides broad protection across multiple delivery methods. Once granted, the patent will include claims covering levosimendan administration through oral, intravenous, inhaled, transdermal, and subcutaneous routes.
The patent also extends protection to levosimendan's active metabolites OR1896 and OR1855 for PH-HFpEF treatment. Additionally, it covers a wide range of levosimendan doses and its use in combination with various cardiovascular drugs for this indication.
Strategic Timing for Global Development
The European patent comes at a critical juncture for Tenax as the company prepares to launch its second registrational Phase 3 study. "The European patent is particularly timely for the Company as we prepare to initiate our second registrational Phase 3 study, LEVEL-2, which will recruit patients across Europe," Giordano stated. "We expect to initiate LEVEL-2 this year, an essential step not only in advancing TNX-103 toward regulatory approval in PH-HFpEF, but also to including patients from around the world at the Phase 3 stage of development."
This European protection builds upon existing patents already issued in the United States and Canada, strengthening Tenax's global intellectual property portfolio for what the company describes as a "novel and potentially first-in-disease drug."
Levosimendan's Clinical Profile
Levosimendan is a first-in-class K-ATP channel activator and calcium sensitizer currently under evaluation for PH-HFpEF treatment. The drug was originally developed for intravenous use in hospitalized patients with acutely decompensated heart failure and has received market authorization in 60 countries for this indication, though it remains unavailable in the United States and Canada.
Tenax's Phase 2 HELP study, including its open-label extension stage, demonstrated levosimendan's potential to deliver durable improvements in exercise capacity and quality of life, along with other clinical assessments in PH-HFpEF patients. TNX-103, the oral formulation, is currently being evaluated in LEVEL, a Phase 3, double-blind, randomized, placebo-controlled clinical trial.
Addressing Unmet Medical Need
PH-HFpEF represents the most prevalent form of pulmonary hypertension globally, yet no product has received approval for this indication to date. Tenax Therapeutics, a Phase 3 development-stage pharmaceutical company, owns global rights to develop and commercialize levosimendan for this condition.
The European patent protection may qualify for supplementary protection certificates (SPC) that could extend the patent term beyond 2040, providing additional commercial exclusivity for this potential first-in-disease treatment.
