The oral formulation will be used to treat pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF). Credit: Towfiqu barbhuiya on Unsplash.

The US Patent and Trademark Office (USPTO) has granted a Notice of Allowance for Tenax Therapeutics’ patent application covering its oral levosimendan, TNX-103, to treat pulmonary hypertension with heart failure with preserved ejection fraction (PH-HFpEF).

Once granted, the patent will offer intellectual property protection until December 2040 and additional protection to the company in the US.

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In March, the USPTO issued a patent for the intravenous administration of levosimendan for the same indication.

Levosimendan serves as a potassium ATP channel activator and a calcium sensitiser.

The latest patent for the drug is based on important findings obtained from the HELP Study.

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Findings showed that PH-HFpEF patients treated with levosimendan had a statistically significant improvement in a six-minute walk distance of 29 metres, compared to a placebo.

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Tenax Therapeutics chief medical officer Dr Stuart Rich said: “Based on its unique mechanistic properties as both a potassium ATP channel activator and calcium sensitiser, 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.

“As demonstrated in the Phase II HELP Study, intravenous levosimendan is the only drug to have shown a significant improvement in exercise capacity for this patient population.

“Importantly, we have also received guidance from the FDA that the same six-minute walking test used in the Phase II HELP Study can serve as the primary endpoint in our Phase III programme.”

Furthermore, the company plans to commence a Phase III trial of the levosimendan oral formulation this year.