US patent approval expected for oral levosimendan for PH-HFpEF

If granted, it would protect intellectual property until December 2040

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by Andrea Lobo |

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Tenax Therapeutics has received a notice of allowance from the U.S. Patent and Trademark Office (USPTO), indicating that a patent for TNX-103 — oral levosimendan — is to be granted.

The patent is expected to cover the use of TNX-103 for treating people with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF). Once granted, it will provide intellectual property (IP) protection until December 2040 and may qualify for patent extension beyond that date.

The company intends to initiate a Phase 3 clinical trial using daily TNX-103 later this year.

“With this Notice of Allowance, Tenax is now exceptionally well-positioned to realize the significant commercial potential of oral levosimendan,” Chris Giordano, CEO of Tenax, said in a company press release. “With these foundational IP rights now in place, we look forward to updating shareholders on our progress as oral levosimendan advances into Phase 3 testing.”

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2 million people could have PH-HFpEF  by 2030

People with PH-HFpEF have a normal heartbeat, but the heart muscle is too stiff to fill properly and pump enough blood to the body. According to Tenax, the condition affects more than 1,600,000 North Americans and is estimated it will affect more than 2,000,000 people by 2030.

According to the American Heart Association scientific advisory (in “A Call to Action,” 2022) PH-HFpEF is “a growing epidemic with high morbidity and mortality and no treatment. The clear unmet need and lethal nature of PH-HFpEF must be met with novel solutions at all levels of therapeutic development.”

Levosimendan works by dilating veins of the splanchnic (abdominal) circulation and lowering the elevated pressure in the heart’s left side that underlies PH-HFpEF. The therapy affects the heart and vascular system through multiple mechanisms of action, Tenax stated.

“Based on its unique mechanistic properties … we believe oral levosimendan has a unique opportunity to become the first therapy ever approved for the treatment of PH-HFpEF, the most common type of PH globally,” said Stuart Rich, MD, Tenax’s chief medical officer.

The company has previously secured a patent protection for under-the-skin (subcutaneous, TNX-102), and into-the-vein (intravenous – IV, TNX-101) administration of levosimendan for the treatment of PH-HFpEF.

The patent covering the use of oral levosimendan for PH-HFpEF is based on data from the Phase 2 trial HELP (NCT03541603), testing a 24-hour-IV weekly dose of levosimendan compared with a placebo.

Results indicated patients receiving levosimendan significantly improved their exercise capacity, measured as an increase of 29 meters (about 95 feet) in the 6-minute walk test.

According to the company, when transitioning to the oral daily formulation in the trial’s open-label extension, the mean distance patients could walk increased by 13.1 meters (nearly 43 feet).

The trial also demonstrated IV levosimendan induces a potent dilation of the central and pulmonary venous circulations, translating into an improvement in exercise capacity.

“As demonstrated in the Phase 2 HELP Study, intravenous levosimendan is the only drug to have shown a significant improvement in exercise capacity for this patient population,” Rich said. “Importantly, we have also received guidance from the FDA that the same 6-minute walking test used in the Phase 2 HELP Study can serve as the primary endpoint in our Phase 3 program.”

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