Print Release
March 12, 2020
Tenax Therapeutics Completes Enrollment in Phase 2 Pulmonary Hypertension Trial
Tenax Therapeutics, Inc. (NASDAQ: TENX) announces enrollment completed in Phase 2 levosimendan HELP study
HELP study exceeds target enrollment with 37 patients
84% initial open-label lead-in response rate to qualify for randomization
Pulmonary capillary wedge pressure (PCWP) was reduced, on average, by 7.5 mmHg during exercise following the initial levosimendan infusion
No serious drug-related adverse events have been reported to date
Top-line data expected in second quarter 2020
Contacts
Westwicke, an ICR Company
Stephanie Carrington, 646-277-1282
Stephanie.carrington@icrinc.com
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 it has completed enrollment of their Phase 2 clinical trial of levosimendan.
The multi-center, double-blind, placebo-controlled Phase 2 trial is designed to evaluate levosimendan in patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF). The study is also known as the HELP Trial ( Hemodynamic Evaluation of Levosimendan in Patients with PH-HFpEF). The primary endpoint is the change from baseline Pulmonary capillary wedge pressure (PCWP) with bicycle exercise (25Watts) at week 6 following five weekly infusions of levosimendan post randomization. There is an 80% power to detect a ≥ 4.8 mmHg reduction in PCWP from baseline. The Company expects to report top-line data in the second quarter 2020.
“We are delighted that enrollment has been completed in this Phase 2 trial and anticipate top line data to be reported during the second quarter 2020 following the completion of dosing and data analysis,” stated Anthony DiTonno, CEO of Tenax Therapeutics. “Pulmonary hypertension due to left heart disease represents a significant unmet medical need given the lack of effective therapies for over an estimated two million patients in the US. Levosimendan with its triple mechanism of action has the potential to represent a breakthrough treatment option for these patients.”
Initial Response
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. 37 of 44 patients who received the open-label lead in infusion, approximately 84%, achieved this predefined responder criterion.
Invasive exercise hemodynamic measurements from the first 30 evaluable patients showed statistically significant improvements during the open-label lead-in phase when compared to baseline, including an average reduction in pulmonary capillary wedge pressure (PCWP) of 7.5 mmHg , an average reduction in pulmonary arterial pressure (mPAP) of 5.1 mmHg, an average reduction in right atrial pressure (RAP) of 5.0 mmHg, and an average increase in cardiac output (CO) of 0.6 liters/min. All of these open-label lead-in phase hemodynamic improvements achieved statistical significance (p≤0.01, paired t-Test)
Adverse Events
There have been no drug-related serious adverse events, and only 1 patient has withdrawn from the study prior to completing the 6-week double-blind phase of the trial . All of the patients who have completed the 6-week double-blind phase of the trial have elected to enroll in the open-label extension study.MBD
