
The U.S. Patent and Trademark Office (USPTO) has granted Tenax Therapeutics a new method of use patent for oral levosimendan to treat pulmonary hypertension associated with heart failure with preserved ejection fraction (PH-HFpEF). Currently, the U.S. Food and Drug Administration (FDA) has not approved any treatments for PH-HFpEF, a condition that affects more than 1.6 million people in North America.
The patent (No. 11,701,355) protects Tenax’s intellectual property (IP) and gives the company exclusive use of the drug therapy (TNX-103) through December 2040. Tenax already has U.S. patents for intravenous (No. 11,607,412) and subcutaneous (No. 11,213,524) methods of the drug to treat PH-HFpEF.
“The advancement of TNX-103 represents a transformative opportunity to establish a treatment for patients with PH-HFpEF,” said Stuart Rich, MD, chief medical officer of Tenax Therapeutics. “This is the most commonly seen patient in pulmonary hypertension referral centers, and yet not a single therapy has been approved for them. Finally, the unmet need of these patients may now be addressed.”
Tenax has already completed a phase 2 HELP study to evaluate the oral levosimendan treatment in improving exercise tolerance in patients who have pulmonary hypertension with HFpEF. The company is working with its Scientific Advisory Board, the FDA and a contract research organization (CRO) to begin its phase 3 trial of TNX-103.