Tenax Therapeutics announced that the first patient has been randomized for its phase 2 trial designed to evaluate levosimendan in patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF).
The study, also known as the HELP Trial (Hemodynamic Evaluation of Levosimendan in Patients with PH-HFpEF), is designed to enroll a total of 36 PH-HFpEF patients at up to approximately 10-12 major research institutions across the US.
Anthony DiTonno, CEO of Tenax Therapeutics, Inc., stated, “Enrolling our first patient is an important milestone for the HELP trial. We have been working closely with our highly regarded principal investigators who are actively screening patients for the trial, and we expect additional centers to start enrolling patients over the coming weeks.”
The HELP Trial is designed to evaluate the hemodynamic benefits of levosimendan, compared to placebo in patients with PH-HFpEF. In addition to the previously conducted preclinical and clinical studies, the trial design has been informed by the substantial clinical experience that comes from more than one million patients who have been treated in over 60 countries where levosimendan is currently approved to treat acute heart failure.
PH-HFpEF represents an area of very high unmet medical need. No approved or effective therapies currently exist to treat the many patients who suffer with PH-HFpEF. Preliminary data from preclinical and clinical studies of pulmonary hypertension and heart failure patients provide a reason to believe that levosimendan may provide important benefits for PH-HFpEF patients.
Tenax Therapeutics is a specialty pharmaceutical company focused on identifying, developing and commercializing products for the critical care market. The Company has a world-class scientific team including recognized global experts in pulmonary hypertension.
The Company owns the North American rights to develop and commercialize levosimendan and is currently enrolling their Phase 2 clinical trial for the use of levosimendan in the treatment of Pulmonary Hypertension associated with Heart Failure and preserved Ejection Fraction (PH-HFpEF).