CHAPEL HILL, N.C. - Tenax Therapeutics, Inc. (NASDAQ:TENX), a company specializing in the development of treatments for cardiovascular and pulmonary diseases, has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for a patent application concerning its heart failure treatment, the company announced today.
The allowed patent application covers the use of levosimendan in various forms, including oral (TNX-103), subcutaneous (TNX-102), and intravenous (IV) (TNX-101), as well as its active metabolites (OR1896 and OR1855), for treating pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF). The patent, which is expected to be granted soon, will extend intellectual property protection for these treatments in the U.S. until December 2040, with the potential for additional extensions.
Levosimendan is a drug that activates potassium ATP channels and sensitizes calcium, which has been shown to improve exercise capacity in patients with PH-HFpEF. This condition is projected to affect around 2 million Americans by 2030 and is currently without an approved drug treatment.
The patent will also cover the use of levosimendan in combination with other cardiovascular drugs, providing Tenax with the opportunity to explore various therapeutic combinations. This development follows the company's recent initiation of the Phase 3 LEVEL study, which is testing the efficacy of oral levosimendan in PH-HFpEF patients.
The LEVEL study is a randomized, placebo-controlled trial that will evaluate the impact of levosimendan on exercise performance, with the primary outcome being the change in six-minute walk distance at Week 12. Participants will have the option to enter a 92-week open-label extension following the initial 12-week study period.
Chris Giordano, President & CEO of Tenax Therapeutics, expressed excitement over the broadening of their IP claims, which supports the future development of drug combinations involving levosimendan. Dr. Stuart Rich, Chief Medical Officer, highlighted the prevalence and severity of PH-HFpEF, underscoring the importance of new treatments for this life-threatening condition.
The news of the patent allowance is based on the results of the Phase 2 HELP trial, which demonstrated significant improvements in exercise capacity for patients treated with IV levosimendan.
The information in this article is based on a press release statement from Tenax Therapeutics.
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