Tenax Granted Notice of Allowance for U.S. Patent Application Covering Use of IV Levosimendan in Pulmonary Hypertension with Heart Failure and Preserved Ejection Fraction (PH-HFpEF)
February 01, 2023 16:31 ET | Source: Tenax Therapeutics
- Patent is expected to provide additional intellectual property protection until 2040
- Prevalence estimates indicate that PH-HFpEF affects over 1,500,000 patients in the U.S.
- There are currently no FDA approved treatments for PH-HFpEF
CHAPEL HILL, N.C., Feb. 01, 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, announced today that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for its patent application with claims covering the use of IV levosimendan in the treatment of pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF). The new claims were made in Tenax Therapeutics’ patent application titled “LEVOSIMENDAN FOR TREATING PULMONARY HYPERTENSION WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION (PH-HFpEF).”
The patent is expected to last until 2040 and will provide the Company with substantial added intellectual property (IP) protection for the use of levosimendan in the treatment of PH-HFpEF patients in the United States. This Notice of Allowance further builds upon the Company’s significant IP for levosimendan, which includes U.S. Patent No. 11,213,524 that was issued in January 2022 and covers all medical uses in humans of the subcutaneous formulation of levosimendan.
Chris Giordano, Tenax Therapeutics’ Chief Executive Officer, stated, “This notice of allowance represents an important milestone in the Company’s development of broad IP protection for the use of levosimendan to treat the estimated 1.5 million-plus patients in the United States who suffer from PH-HFpEF and who currently have no FDA approved therapies to treat their condition. The protections this patent will provide are based on key discoveries from the HELP Study – the first study to demonstrate improved exercise tolerance in patients with this deadly disease. USPTO’s acknowledgement of the novelty of this targeted use of levosimendan increases our confidence that our pending patent applications, which are based on further data from the HELP patients who transitioned from IV to oral levosimendan, will also be afforded IP protection.”
The results of the HELP Study showed that levosimendan-treated PH-HFpEF patients benefited from a statistically significant improvement in 6-minute walk distance of 29 meters (p=0.03) when compared with placebo. When transitioning to the oral daily formulation after a lengthy treatment with the weekly IV formulation, the 6-minute walk results improved further. FDA has confirmed to Tenax Therapeutics that the six-minute walk distance endpoint is acceptable for a Phase 3 registration program for the treatment of PH-HFpEF.
Dr. Stuart Rich, Chief Medical Officer of Tenax Therapeutics, stated, “A recent American Heart Association Science Advisory* remarked that PH-HFpEF is a growing epidemic with high mortality that must be met with novel solutions. Levosimendan is the first therapy to show clinical benefit in a randomized controlled trial in this population. We expect the granting of this IP protection will allow us to proceed with the development of a desperately needed treatment for these patients.”
* Brittain, Evan L., et al. "Elucidating the Clinical Implications and Pathophysiology of Pulmonary Hypertension in Heart Failure With Preserved Ejection Fraction: A Call to Action: A Science Advisory From the American Heart Association."
Circulation 146.7 (2022): e73-e88