Tenax Therapeutics Announces Last Patient Completes Final Visit in its Phase 2 “HELP Study” of Levosimendan for Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction
Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, today announced that the last patient has completed their final visit in the Company’s Phase 2 clinical trial of levosimendan in patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF). The study is also known as the HELP Study (Hemodynamic Evaluation of Levosimendan in Patients with PH-HFpEF).
- The 36-subject clinical trial began enrollment in late March 2019 and patients were randomized in 10 hospitals across the U.S.
- Trial finalization leading to data lock and top-line data readout has now begun.
- Top-line data readout remains on track for late June 2020
PH-HFpEF represents an area of very high unmet medical need. PH-HFpEF patients suffer from increased mortality as well as a reduced quality of life. No approved or effective therapies currently exist to treat the many patients who suffer with PH-HFpEF.
Tenax CEO Tony Di Tonno stated: “We are thankful for the dedicated physicians, study coordinators and home health providers who were able to close out our study with minimal disruption from the current COVID-19 pandemic crisis. We are continuing to work very closely with everyone involved in collecting and finalizing the data required to report top line data before the end of the second quarter.”
Dr. Stuart Rich, Director of the Pulmonary Vascular Disease Program at the Bluhm Cardiovascular Institute at Northwestern University stated, “As a principal investigator who helped to design and execute the HELP Study, I am eagerly looking forward to seeing the results of the HELP Study. Based on the remarkably favorable response reported by investigators during the open label pre-randomization phase of the trial, I am hopeful the results of the randomized double-blind phase of the trial will demonstrate that levosimendan could represent a breakthrough therapy for PH-HFpEF patients.”
About Phase 2 HELP Study
The HELP Study is a multi-center, double-blind, placebo-controlled Phase 2 clinical trial designed to evaluate levosimendan in 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 was a reduction in PCWP during supine exercise of ≥ 4mmHg following the open-label infusion when compared with each patient’s baseline exercise PCWP. 37 of 44 patients, approximately 84%, achieved this predefined responder criterion. Investigator reported invasive exercise hemodynamic measurements from 35 evaluable patients showed statistically significant improvements during the open-label lead-in phase when compared to baseline, including an average reduction of 7.8 mmHg PCWP, an average reduction in pulmonary arterial pressure (mPAP) of 4.8mmHg, an average reduction in right atrial pressure (RAP) of 5.3 mmHg, and an average increase in cardiac output (CO) of 0.4 liters/min. All of these open-label lead-in phase hemodynamic improvements, with the exception of cardiac output, achieved statistical significance (P≤0.001, paired t-Test).
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