Tenax acquires global rights to oral, subcutaneous levosimendan

Therapy reduces amount of blood putting pressure on blood vessel walls

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by Andrea Lobo |

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Tenax Therapeutics has secured global rights to oral and subcutaneous (under the skin) formulations of levosimendan, a potential therapy for pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF).

Under a licensing agreement established with Orion Corp. in 2013, Tenax acquired developmental and commercial rights of intravenous (into the vein) levosimendan for the U.S. and Canada, which was later extended to cover the oral formulation.

The now expanded agreement extends Tenax’s rights globally. According to Tenax, it makes it possible to establish collaborations with pharmaceutical partners.

“By gaining these worldwide rights, we are now positioned to realize a much larger share of this unique and exciting cardiovascular medicine’s value, including through the possible establishment of a global strategic alliance,” Chris Giordano, Tenax’s president and CEO, said in a company press release.

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Orion to receive payment as milestones met

Under the terms of the agreement, milestones to be paid to Orion will be based on net sales and certain regulatory approvals, including one expected in Japan.

“We are delighted to enter into this important amendment to our license from Orion. We have achieved a key corporate objective by expanding our development, IP, and commercial territory rights for levosimendan beyond North America,” Giordano said.

People with PH-HFpEF pump a normal amount of blood with every heartbeat, but the heart muscle is too stiff to relax properly with the left side of the heart failing to keep up with the blood returning from the lungs, leading to PH.

Levosimendan is thought to work by relaxing blood vessels via activation of a potassium channel, and reducing the amount of blood putting pressure on blood vessels’ walls. It also has protective effects on the heart muscle and promotes heart contraction.

Earlier this month, Tenax received a notice of allowance from the U.S. Patent and Trademark Office for a patent covering use of levosimendan in PH-HFpEF given orally (TNX-103), subcutaneously (TNX-102), or intravenously (TNX-101). If issued, it will be valid through 2040.

The patent also covers active metabolites — products of levosimendan metabolism in the body — as well as the use of levosimendan alone or in combination with medications for heart and blood vessel conditions. It adds to previous patents granted in the U.S. covering all three routes of administration of levosimendan.

“Our efforts to secure global commercial rights and leverage the additional potential IP protection around the world enable us to build significant shareholder value as we advance levosimendan into Phase 3 testing,” Giordano said.

The company has recently started enrolling patients in a Phase 3 clinical trial of TNX-103 in people with PH-HFpEF. The LEVEL trial (NCT05983250) expects to enroll 152 adults with PH-HFpEF, ages 18-85, at three U.S. sites. LEVEL stands for LEVosimendan to Improve Exercise Limitation in Patients with PH-HFpEF.

Patients will be randomly assigned to receive oral levosimendan, at a dose of 2 mg/day for weeks one to four and then 3 mg per day up to week 12, or a placebo. Its main goal is to evaluate treatment efficacy in improving exercise capacity, by measuring six-minute walk distance.

In the Phase 2 HELP trial (NCT03541603) that tested the intravenous TNX-101 formulation in 38 adults with PH-HFpEF, weekly infusions of levosimendan reduced pressure on the heart and improved exercise capacity, compared to a placebo.

Moreover, data from the trial’s open-label extension showed that switching from intravenous to oral levosimendan was well tolerated and further improved exercise capacity.

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