Tenax Therapeutics Introduces Fresh U.S. Patent Covering Levosimendan Usage in Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF)
2 May 2024
Tenax Therapeutics, Inc. (Nasdaq: TENX) has announced that the United States Patent and Trademark Office (USPTO) has granted the company a patent covering the use of several forms of levosimendan, along with its active metabolites and combinations with cardiovascular drugs, for enhancing exercise performance in PH-HFpEF patients. The patent, titled "LEVOSIMENDAN FOR TREATING PULMONARY HYPERTENSION WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION (PH-HFpEF)," aims to safeguard the commercial value of their innovative treatment.
Tenax Therapeutics, emphasized the importance of expanding their intellectual property estate for levosimendan, stating that it is critical for protecting the future commercial value of their treatment for PH-HFpEF. The patent, numbered 11,969,424, extends protections until December 2040, covering various administration methods and dosages of levosimendan, as well as combinations with cardiovascular drugs for treating PH-HFpEF patients.
The patent builds upon findings from the HELP Study conducted by Tenax Therapeutics, which demonstrated a significant improvement in exercise performance in PH-HFpEF patients treated with levosimendan compared to those receiving a placebo. These findings form the basis of the ongoing Phase 3 LEVEL study.
The LEVEL Study (NCT05983250) is a Phase 3 clinical trial investigating levosimendan in PH-HFpEF patients. Approximately 152 subjects will be randomized to receive oral levosimendan or placebo for 12 weeks, with the primary outcome measure being the change in six-minute walk distance. Following completion of the study, all subjects will have the option to enter the 92-week open-label extension (OLE).
Levosimendan (TNX-101, TNX-102, TNX-103) is a potassium ATP channel activator and calcium sensitizer with multiple mechanisms of action on the heart and vascular system. Initially developed by Orion Corporation in Finland, intravenous levosimendan is approved in numerous countries outside the United States for acutely decompensated heart failure. Tenax Therapeutics aims to address the urgent need for effective treatments for PH-HFpEF, a condition with high morbidity and mortality and currently no established treatments.
Source: globenewswire.com