Therapy Areas: Cardiovascular
Tenax Therapeutics Completes Enrollment in Phase 2 Pulmonary Hypertension Trial
13 March 2020 - - US-based specialty pharmaceutical company Tenax Therapeutics, Inc. (NASDAQ: TENX) has completed enrollment of their Phase 2 clinical trial of levosimendan, the company said.

The multi-centre, 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 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 2Q20.

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 randomisation 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 of 7.5 mmHg, an average reduction in pulmonary arterial pressure of 5.1 mmHg, an average reduction in right atrial pressure of 5.0 mmHg, and an average increase in cardiac output of 0.6 liters/min.

All of these open-label lead-in phase hemodynamic improvements achieved statistical significance (p≤0.01, paired t-Test).

There have been no drug-related serious adverse events, and only 1 patient has withdrawn from the study prior to completing the 6-week double-blind phase of the trial.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.

Tenax Therapeutics is a specialty pharmaceutical company focused on identifying, developing and commercialising products that address cardiovascular and pulmonary diseases with high unmet medical need.

The company has a world-class scientific team including recognized global experts in pulmonary hypertension.

The company owns North American rights to develop and commercialize levosimendan and has completed enrollment of 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).

Levosimendan is a calcium sensitizer that works through a unique triple mechanism of action.

It initially was developed for intravenous use in hospitalised patients with acutely decompensated heart failure. It was discovered and developed by Orion Pharma, Orion Corp. of Espoo Finland, and is currently approved in over 60 countries for this indication and not available in the United States.

Tenax Therapeutics acquired North American rights to develop and commercialise levosimendan from Phyxius Pharma, Inc.
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