A new Phase 2 study evaluating Tenax Therapeutic’s investigational levosimendan as a therapy for pulmonary hypertension (PH) associated with heart failure and preserved left ventricular ejection fraction (PH-HFpEF) — a type of PH related to left heart disease – will soon begin recruiting participants, the company announced.
Patients with PH-HFpEF have no approved therapies for their condition and, although several pulmonary arterial hypertension (PAH) treatments have been investigated, none has proven effective.
Levosimendan is a calcium sensitizer/K-ATP activator that was shown to increase heart contractility and vasodilation (opening of blood vessels, resulting in lower blood pressure). It may also have protective effects by easing the burden on heart muscle cells.
The trial (NCT03541603), due to open in August, will enroll 36 people with PH-HFpEF to test whether levosimendan can improve hemodynamic measures (related to blood flow) as seen in exercise capacity and functional abilities.
All study participants will be given levosimendan for an initial two weeks. Patients responding to this initial load will then be randomized to receive levosimendan or a placebo for an additional four weeks.
Levosimendan is administered in weekly intravenous (directly into the blood) doses of 50 microgram/min.
The trial’s primary goal is to determine levosimendan’s ability to improving pressure in the left side of the heart while patients undergo bicycle exercise.
Secondary goals include the assessment of additional pulmonary and heart function parameters, such as pulmonary vascular resistance (the resistance in the pulmonary artery against blood flow), and changes in exercise duration.
“We are very pleased to begin this new Phase 2 study, which has been designed in collaboration with leading pulmonary hypertension and HFpEF experts to efficiently evaluate the effectiveness of levosimendan in this patient population,” Michael Jebsen, interim CEO of Tenax, said in a press release.
“The estimated prevalence of PH-HFpEF in the U.S. is high, with some estimates exceeding 1.5 million patients. PH-HFpEF patients have increased mortality and morbidity, as well as suffer from reduced exercise capacity and quality of life,” Jebsen added. “If levosimendan can improve their hemodynamic function, the improvements in their quality of life could be significant.”
The trial’s launch follows the U.S. Food and Drug Administration’s (FDA) approval earlier this year of the study’s design and proposed endpoints. Patients will be enrolled at between 20 and 25 sites, Tenax said in the release.
Tenax acquired the North American rights to develop and commercialize levosimendan from Phyxius Pharma.