Tenax Announces Late-Breaking Results from the HELP Study Accepted for Presentation at the Heart Failure Society of America (HFSA) Annual Scientific Meeting
Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products for the critical care market, today announced that detailed results from the Phase 2 HELP Study of levosimendan in PH-HFpEF have been accepted for presentation as a Late-Breaking Clinical Trial at this year’s Heart Failure Society of America (HFSA) Annual Scientific Meeting to be held September 30, 2020-October 6, 2020.
The HELP Study (Hemodynamic Evaluation of Levosimendan in PH-HFpEF) was a multi-center, double-blind, placebo-controlled Phase 2 clinical trial designed to evaluate levosimendan in 36 patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF). Endpoints in the trial evaluated various invasive hemodynamic and clinical measures including a 6-minute walk test.
Detailed results of the HELP Study will be presented as a late-breaking oral abstract by Dr. Barry Borlaug, Chair for Research, Division of Circulatory Failure, Department of Cardiovascular Medicine at the Mayo Clinic and a member of the HELP Study Steering Committee.
Tenax CEO Anthony DiTonno stated “We are very excited to have the HELP Study results accepted for presentation as a late-breaking abstract at the HFSA Annual Meeting. The positive results of the HELP Study represent a major milestone for Tenax and our development of levosimendan for the treatment of patients suffering from this debilitating illness. Based on feedback from our advisors, we believe the results may represent a potential breakthrough in the treatment of PH-HFpEF patients, and we look forward to having the detailed trial results presented at this major scientific forum.”
About Phase 2 HELP Trial
The HELP Trial – Hemodynamic Evaluation of Levosimendan in PH-HFpEF is a multi-center, double-blind, placebo-controlled Phase 2 clinical trial designed to evaluate levosimendan in 36 patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF). The trial has a predefined response criterion that patients must meet following a 24-hour open-label infusion of levosimendan before they can be randomized to the 6-week double-blind phase of the trial. The criterion for randomization is a reduction in PCWP during supine exercise of ≥ 4mmHg following the open-label infusion when compared with each patient’s baseline exercise PCWP. The primary endpoint of the HELP Trial is based on change in PCWP vs baseline compared to placebo.