Tenax sees European patent for levosimendan to treat PH-HFpEF
European Patent Office tells company it will grant patent protecting use
The European Patent Office has given Tenax Therapeutics notice that it plans to grant a patent covering the use of levosimendan and its active metabolites to treat pulmonary hypertension associated with heart failure with preserved ejection fraction (PH-HFpEF), the company said.
TNX-103, an oral formulation currently in Phase 3 testing for PH-HFpEF, is among the versions of levosimendan included in the patent.
The patent will prohibit others from developing TNX-103 or other covered molecules and formulations for PH-HFpEF. It will be valid in Europe through 2040, and may qualify for an additional patent term beyond that. Similar patents have been issued in the U.S. and Canada.
“This patent will protect our use of levosimendan in PH-HFpEF, including TNX-103, in Europe,” Chris Giordano, president and CEO of Tenax, said in a company press release.
Giordano said the European patent is “particularly timely,” because the company is preparing to launch LEVEL-2, a Phase 3 trial of TNX-103 that will recruit PH-HFpEF patients across Europe.
Trial in U.S., Canada recruiting patients
Another Phase 3 trial, LEVEL (NCT05983250), is underway in the U.S. and Canada, where recruitment is ongoing. The study is primarily testing the ability of TNX-103 to improve exercise capacity in adults with PH-HFpEF.
The company has received approximately $100 million in funding to support LEVEL, and announced earlier this year that it was expanding its Phase 3 program for TNX-103.
“We expect to initiate LEVEL-2 this year, an essential step not only in advancing TNX-103 toward regulatory approval in PH-HFpEF, but also to including patients from around the world at the Phase 3 stage of development,” Giordano said.
Pulmonary hypertension is characterized by elevated pressure in the blood vessels that carry blood from the heart to the lungs. PH-HFpEF is a form of the condition that’s caused by disease on the left side of the heart.
In PH-HFpEF, the heart’s left ventricle, responsible for pumping oxygen-rich blood coming from the lungs out to the rest of the body, contracts and pumps blood at a normal rate. However, it can’t fill up properly with blood in between heartbeats, which leads to increased pressure that backs up into the lungs.
Levosimendan is believed to work in multiple ways. First, it activates specific potassium channels in blood vessels, helping them relax and facilitating blood flow. Second, it binds to proteins in heart muscles and makes them more sensitive to calcium, making it easier for the heart muscle to contract.
The molecule is approved in several countries outside North America for treating advanced heart failure. However, it does not have regulatory clearance anywhere for PH-HFpEF.
In a previous Phase 2 trial called HELP (NCT03541603), weekly infusions of TNX-101, a formulation of levosimendan that’s infused into the bloodstream, reduced heart pressure and improved exercise capacity in adults with PH-HFpEF.
Switching from TNX-101 to an oral formulation in the study’s open-label extension (OLE) was well tolerated and led to further clinical improvement.
LEVEL participants are randomly assigned to receive daily TNX-103 or a placebo for about three months. The study’s primary goal is to evaluate changes in exercise capacity, as assessed by the six-minute walk test. The main study will be followed by an OLE, where all will receive TNX-103 for nearly two years.
Top-line data from LEVEL are expected next year. In LEVEL-2, participants will receive the therapy at a dose of 2 mg/day for the first four weeks and 3 mg/day from week five onward, or a placebo. This trial also has assessing exercise capacity as its main goal, at nearly six months.
In addition to TNX-103, the European patent will cover other routes of administration for levosimendan, including versions that are inhaled, absorbed through the skin (transdermal), injected into a vein (intravenous), or injected under the skin (subcutaneous).
Tenax said a “wide range” of levosimendan doses and the use of levosimendan in combination with various cardiovascular medications will be patent-protected. The patent also extends protection to OR1896 and OR1855, which are active metabolites of levosimendan.
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