New US patent for levosimendanin covers all PH-HFpEF formulations
Tenax therapy now protected through 2040 to improve exercise performance
Tenax Therapeutics has been granted another U.S. patent for levosimendan, this one covering all three routes of administration and its active metabolites, for the treatment of people with PH-HFpEF, or pulmonary hypertension and heart failure with preserved ejection fraction.
Issued by the U.S. Patent and Trademark Office, the patent protects the use of levosimendan to improve exercise performance among PH-HFpEF patients.
It covers the medication when given orally (TNX-103), under the skin (TNX-102), or into the vein (TNX-101) in intravenous administration, as well as its active metabolites — OR1896 and OR1855 — at all therapeutic doses. Combinations of levosimendan with medications for cardiovascular disorders also are included. Active metabolites are products of levosimendan metabolism in the body.
The patent provides protection through 2040, though an extension is possible. This is the third levosimendan patent granted for PH-HFpEF treatment since March 2023. Tenax recently secured the global rights to the oral and subcutaneous or under-the-skin formulations of levosimendan.
“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,” Chris Giordano, the company’s president and CEO, said in a press release.
“The important, additional IP [intellectual property] 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,” Giordano said.
Ongoing LEVEL study testing oral levosimendan against a placebo
In people with PH-HFpEF, the heart is able to pump a normal volume of blood with every heartbeat. However, the heart muscle is not able to relax properly. This is the result of heart muscle stiffness, which makes the left side of the heart fail to keep up with the blood coming from the lungs, leading to PH.
Levosimendan is believed to help relax blood vessels and reduce the amount of blood putting pressure on the blood vessels’ walls.
The new patent was supported by data from HELP (NCT03541603), in which adults with PH-HFpEF treated with weekly infusions of TNX-101 had a reduction in the pressure on the left heart and improved exercise capacity when compared with a placebo.
Participants in the study were then able to join an open-label extension of HELP during which they received TNX-103 — the oral formulation — once daily. The treatment was well tolerated and further improved exercise capacity.
These findings supported the launch of LEVEL (NCT05983250), a Phase 3 study that will compare TNX-103 to a placebo in PH-HFpEF patients. A lower (2 mg/day) dose will be administered in weeks 1 to 4, and a higher dose (3 mg/day) in weeks 5 to 12.
That study’s main goal is to measure the change in six-minute walk distance, a commonly used measure to assess exercise capacity. All participants will be able to enter an open-label extension i which each patient will receive TNX-103, for a total of two years on therapy.
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