Tenax Granted US Patent for Levosimendan as Treatment for PH
Company developing IV formulation as first for PH with heart failure
The experimental therapy levosimendan has been awarded a U.S. patent covering its use for pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF), according to developer Tenax Therapeutics.
The United States Patent and Trademark Office (USPTO) issued a notice of allowance to Tenax for a patent for an intravenous (IV or into-the-vein) formulation of the treatment candidate.
The patent is slated to last through 2040.
“We expect the granting of this IP [intellectual property] protection will allow us to proceed with the development of a desperately needed treatment for these patients,” Stuart Rich, MD, chief medical officer of Tenax, said in a company press release.
PH-HFpEF is characterized by a normal heartbeat, but the heart muscle is too stiff to fill properly. There are no therapies approved by the U.S. Food and Drug Administration (FDA) for PH-HFpEF.
Levosimendan in development for PH-HFpEF
Levosimendan is thought to work by reducing the amount of blood putting pressure on circulatory vessels. The USPTO’s issue of allowance specifically covers a formulation of levosimendan that is administered intravenously, via infusion into the bloodstream. Tenax has previously received patent protection covering a version of the therapy called TNX-102 that’s given by under-the-skin (subcutaneous) injection.
“This notice of allowance represents an important milestone in the company’s development of broad IP protection for the use of levosimendan to treat the estimated 1.5 million-plus patients in the United States who suffer from PH-HFpEF,” said Chris Giordano, CEO of Tenax.
The new patent was supported by data from the Phase 2 HELP clinical trial (NCT03541603), which enrolled 38 adults with PH-HFpEF. The mean age among the participants was 68.1. Each was randomly assigned to receive levosimendan or a placebo.
Results from the trial indicated that most patients given levosimendan experienced an improvement in six-minute walk distance, a common measure of exercise capacity. The average improvement of levosimendan compared with the placebo was 29 meters (about 95 feet) and was statistically significant.
“The protections this patent will provide are based on key discoveries from the HELP Study – the first study to demonstrate improved exercise tolerance in patients with [PH-HFpEF],” Giordano said.
Added Rich: “Levosimendan is the first therapy to show clinical benefit in a randomized controlled trial in this population.”
This notice of allowance represents an important milestone in the company’s development of broad IP protection for the use of levosimendan to treat the estimated 1.5 million-plus patients in the United States who suffer from PH-HFpEF.
Tenax also is developing an oral formulation of levosimendan. Recent data from the open-label extension phase of the HELP study suggested that switching from the intravenous to oral formulation was well tolerated, with data hinting that the oral version might be more effective in terms of exercise capacity and lowering levels of heart damage markers.
“USPTO’s acknowledgement of the novelty of this targeted use of levosimendan increases our confidence that our pending patent applications, which are based on further data from the HELP patients who transitioned from IV to oral levosimendan, will also be afforded IP protection,” Giordano said.
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