Tenax Therapeutics Announces USPTO Grants Notice of Allowance for U.S. Patent Application, Significantly Broadening IP Protection for Use of Levosimendan in Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF)
Once granted, this patent will:
CHAPEL HILL, N.C., Feb. 06, 2024 (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 allowed its patent application with claims covering the use of TNX-103 (oral levosimendan), TNX-102 (subcutaneous levosimendan), TNX-101 (IV levosimendan), the active metabolites of levosimendan (OR1896 and OR18955) and various combinations of cardiovascular drugs with levosimendan when used to improve exercise performance in PH-HFpEF patients and, titled: ”LEVOSIMENDAN FOR TREATING PULMONARY HYPERTENSION WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION (PH-HFpEF).”
This new patent, once granted, will provide significant added IP protection through December 2040. The Notice of Allowance indicates that the USPTO plans to grant Tenax expanded IP rights to the use of oral, subcutaneous, and intravenous (IV) administration of levosimendan, as well as its active metabolites (OR1896 and OR1855) for the treatment of PH-HFpEF, at all therapeutic doses. It also indicates that IP protection will be provided for the use of combinations with various cardiovascular drugs, when used in PH-HFpEF patients.
“We are excited to receive a Notice of Allowance of another U.S. patent that will significantly broaden our existing IP claims, including coverage of expanded dose ranges and the combination of levosimendan and other drugs for use in PH-HFpEF. This provides additional rationale for the future development of various drug-drug combinations with levosimendan,” said Chris Giordano, President & Chief Executive Officer of Tenax Therapeutics. “Today’s patent news adds to the excitement generated by the recent initiation of investigative sites for our Phase 3 LEVEL study.”
Dr. Stuart Rich, Chief Medical Officer of Tenax Therapeutics, stated, “Studies on PH-HFpEF suggest that this heart failure condition is more prevalent than many physicians appreciate, with a projected incidence of approximately 2 million Americans by 2030, and with outcomes and mortality at least as poor as those observed in patints with HFpEF alone. With no drugs yet approved for PH-HFpEF, levosimendan has already demonstrated its unique mechanism of action, K+ATP activation, in these patients. Having this additional patent protection for its use in combination with other cardiovascular drugs, and via multiple routes of administration, affords Tenax the opportunity to evaluate the clinical utility of levosimendan in other related areas of cardiovascular disease.”
The patents covering the use of IV and oral levosimendan for the treatment of PH-HFpEF rely on key discoveries Tenax Therapeutics made with the HELP Study, in which levosimendan-treated PH-HFpEF patients benefited from a statistically significant improvement in 6-minute walk distance of 29 meters (p=0.03) when IV levosimendan was compared with placebo. Patients who transitioned to the oral daily formulation after a lengthy treatment with the weekly IV formulation improved further in their 6-minute walk results.
About the Phase 3 LEVEL Study (NCT05983250)
About Levosimendan (TNX-101, TNX-102, TNX-103)
About Tenax Therapeutics
Tenax Therapeutics, Inc. is a specialty pharmaceutical company focused on identifying, developing, and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need. The Company owns North American rights to develop and commercialize IV, subcutaneous, and oral formulations of levosimendan. Tenax Therapeutics also is developing a unique oral formulation of imatinib. For more information, visit www.tenaxthera.com. Tenax’s common stock is listed on The Nasdaq Stock Market LLC under the symbol “TENX”.
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