Tenax Therapeutics has secured a new method of use patent from the US Patent and Trademark Office (USPTO) for oral levosimendan (TNX-103) to treat pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF).

Levosimendan is a potassium ATP channel activator and calcium sensitizer that targets the heart and vascular system via different mechanisms of action.

The oral levosimendan treatment for PH-HFpEF is covered by the issued patent (US Patent No. 11,701,355), which grants exclusivity until December 2040.

The ‘355 patent adds to the company’s extensive intellectual property, which already consists of issued US patents for the use of levosimendan formulations for the treatment of PH-HFpEF via intravenous and subcutaneous routes.

Tenax Therapeutics CEO Chris Giordano said: “The issuance of patent ‘355 is a very important achievement in protecting the discoveries made with the HELP Study, while also preserving for our shareholders the substantial commercial value of potentially developing the first drug to treat this large and underserved patient population.

“With this patent now in hand, providing us a potential commercial runway to December 2040, we are excited to be moving into Phase 3 testing with the oral formulation, where we hope to demonstrate the ability of TNX-103 to address this significant unmet need in patients with PH-HFpEF.”

Discovered and developed by Orion Corporation, intravenous levosimendan is authorised in more than 58 countries outside the US for use in hospitalised patients with acutely decompensated heart failure.

Results of Tenax’s Phase 2 HELP trial of levosimendan in patients with pulmonary hypertension and HFpEF showed that IV levosimendan produces strong dilation of the central and pulmonary venous circulations, which translates into an improvement in exercise capacity.

Additionally, the firm plans to start a Phase 3 trial using TNX-103 in 2023 in coordination with its Scientific Advisory Board, the US Food and Drug Administration (FDA), and its contract research organisation (CRO) partner.