Benzinga | Jan 12, 2022 08:37AM EST

Tenax Thearpeutics Reports Was Granted US Patent For Subcutaneous Use Of Levosimendan

Provides Broad Coverage for Use of TNX-102 for the Treatment of Human Subjects with Any Health Condition

Patent Term to 2039, Exclusive of Any Possible Extensions

MORRISVILLE, N.C., Jan. 12, 2022 (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 the United States Patent and Trademark Office (USPTO) has granted a patent for the company's subcutaneous formulation of levosimendan, TNX-102, which is currently being developed for the treatment of pulmonary hypertension associated with left heart failure (PH-HFpEF).

On January 4, 2022, Tenax Therapeutics was issued US Pat. No. 11,213,524, entitled PHARMACEUTICAL COMPOSITIONS FOR SUBCUTANEOUS ADMINISTRATION OF LEVOSIMENDAN, which is directed towards the use of levosimendan via subcutaneous administration for treating a subject having a health condition of any kind, such as heart failure, pulmonary hypertension including PH-HFpEF, chronic kidney disease, stroke, or other health conditions. The patent is expected to expire no earlier than 2039, exclusive of any possible extensions. Tenax Therapeutics also has a PCT international application pending, with a US counterpart already under examination, that describes and claims methods of treating Tenax's first intended clinical indication, PH-HFpEF, by providing levosimendan by any route of administration.

"With this newly issued U.S. patent, Tenax has secured claims covering the use of subcutaneous levosimendan, not only for the treatment of PH-HFpEF, but for any future cardiovascular indication where the drug could be used," said Dr. Stuart Rich, Chief Medical Officer of Tenax Therapeutics. "As we learned in our HELP trial, levosimendan's unique effectiveness results from its actions on the venous circulation in heart failure patients. We believe levosimendan has the opportunity to address a significant unmet medical need in cardiovascular diseases by becoming the first approved treatment for pulmonary hypertension due to left heart failure -- a condition afflicting millions of patients and for which there are no currently approved therapies."

The Phase 2 HELP trial was designed to evaluate levosimendan as a treatment of PH-HFpEF, a progressive and fatal disease for which no approved treatment exists. The results from this study led to the discovery that levosimendan works as a potassium-ATP channel activator in reducing the elevated central venous and pulmonary venous pressures in PH-HFpEF patients. As a result of observations from the HELP trial, Tenax Therapeutics believes that levosimendan could have significant therapeutic benefit for patients with PH-HFpEF (Group 2 pulmonary hypertension).

"Extending patent protection for our lead drug candidates continues to be an important strategic focus for Tenax," said Christopher T. Giordano, President and Chief Executive Officer of Tenax Therapeutics. "The issuance of the '524 patent represents a key expansion of our IP portfolio, and we expect to secure additional patent protections for our lead drug programs to help build significant future value for our shareholders as we advance our lead drug candidates into pivotal Phase 3 testing."