Tenax Therapeutics Announces Study Design for Phase 2 Trial of Levosimendan in PH-HFpEF Patients

June 6, 2018

Tenax Therapeutics, Inc. (TENX), a specialty pharmaceutical company focused on providing products to address conditions with significant unmet medical needs, today announced the registration of their Phase 2 clinical trial in the use of levosimendan for treatment of Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF) on ClinicalTrials.gov.

The Phase 2 PH-HFpEF study is a multi-center, double blind, randomized, placebo-controlled clinical trial that is testing the hypothesis that chronic, intermittent doses of levosimendan will significantly improve hemodynamic measures of exercise performance in patients suffering from Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction. PH-HFpEF patients will be enrolled at a targeted 20-25 sites, in an open-label lead-in phase of the study. Subjects who have responded positively to the first hospital-administered dose of levosimendan will be randomized in the study and receive levosimendan or placebo for four additional weekly treatments. The study is expected to be initiated in the third quarter.

“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,” said Michael Jebsen, Interim CEO of Tenax. “The estimated prevalence of PH-HFpEF in the US 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. There are no drugs approved to treat this condition. If levosimendan can improve their hemodynamic function, the improvements in their quality of life could be significant.”

For more information, visit www.tenaxthera.com.


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