Plans for a Phase 2 clinical trial of levosimendan, a proposed treatment for pulmonary hypertension associated with heart failure and preserved ejection fraction, will soon be submitted to the U.S. Food and Drug Administration for approval, Tenax Therapeutics announced.
In a pre-application meeting with company executives, the FDA supported the study’s proposed design and measures that will be used to demonstrate proof-of-concept in people with pulmonary hypertension associated with heart failure and preserved ejection fraction, or PH-HFpEF patients, Tenax said in a press release.
An Investigational New Drug application will soon be submitted, and the trial is expected to open in the summer.
PH can result from heart failure, where the heart’s ability to pump blood is defective. In cases of HFpEF, which is also called diastolic heart failure, the heart’s left ventricle works poorly but is able to pump blood at a rate more than 50 percent the normal value.
Levosimendan was discovered and developed by Orion, a pharmaceutical company based in Finland. It is used in more than 60 countries to treat heart failure, but is not an approved therapy in the U.S. In Europe, it is marketed under the name Simdax.
Tenax, a North Carolina-based company, acquired the rights to develop and commercialize levosimendan in North America.
Levosimendan is a calcium sensitizer/K-ATP activator. It increases heart contractility, promotes vasodilation (opening of blood vessels, resulting in lower blood pressure), and has protective effects by easing the burden on heart muscle cells.
“We are very pleased with the outcome of the pre-IND meeting,” Michael Jebsen, interim CEO of Tenax, said in the release. “The initial pathway to move forward with the development of levosimendan in PH-HFpEF has been clarified and confirmed. We will finalize our Phase 2 clinical trial protocol for IND submission and continue preparations for a late June or July start of the trial.”
No therapies are approved to treat PH-HFpEF. Several pulmonary arterial hypertension (PAH) treatments have been investigated as possible PH-HFpEF therapies, but none have proven to be effective.
Given the high prevalence (over 1.5 million people in the U.S.), poor associated outcomes, and complete lack of effective treatments for this condition, PH-HFpEF is considered a disease with a high and unmet medical need.