Tenax receives patent for TNX-103, oral levosimendan, for PH-HFpEF

Phase 3 clinical trial testing the therapy expected to begin by end of year

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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Tenax Therapeutics has been issued a U.S. patent covering oral levosimendan, also known as TNX-103, for the treatment of pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF).

The patent (U.S. Patent No. 11,701,355) is expected to provide intellectual property protection for TNX-103 through December 2040. The patent was issued about a month after Tenax received a notice of allowance from the U.S. Patent and Trademark Office.

Tenax now is planning to launch a Phase 3 clinical trial to test the experimental therapy in people with PH-HFpEF. The study is expected to begin before the end of the year, according to the company.

“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,” Chris Giordano, CEO of Tenax, said in a company press release.

Like other types of pulmonary hypertension, PH-HFpEF is characterized by abnormally high pressure in the lung’s blood vessels. In PH-HFpEF, the heart beats normally, but is too stiff to adequately pump blood out through the body.

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There currently are no approved treatments for this type of pulmonary hypertension, even though it’s comparatively common: PH-HFpEF is estimated to affect more than 1,600,000 people in North America, according to Tenax.

“The advancement of TNX-103 represents a transformative opportunity to establish a treatment for patients with PH-HFpEF. This is the most commonly seen patient in pulmonary hypertension referral centers, and yet not a single therapy has been approved for them,” said Stuart Rich, MD, Tenax’s chief medical officer. “Finally, the unmet need of these patients may now be addressed.”

Levosimendan is thought to work by widening blood vessels in the abdomen, which results in lower stressed blood volume — the amount of blood putting pressure on the body’s blood vessels.

TNX-101, TNX-102 previously given patent protection

Tenax has previously secured patent protection for TNX-101, a formulation of levosimendan given intravenously (into the bloodstream), and TNX-102, a formulation given by subcutaneous (under-the-skin) injection. The company acquired rights to the oral formulation in 2020.

Tenax previously sponsored a Phase 2 clinical trial called HELP (NCT03541603) that tested the intravenous formulation against a placebo in people with PH-HFpEF. Results indicated the treatment reduced pressure on the heart and improved exercise capacity, and data from the trial’s extension phase suggested switching from intravenous to oral levosimendan was generally well tolerated.

According to Giordano, the new patent covering oral levosimendan “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.”

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