MORRISVILLE, N.C.--(BUSINESS WIRE)--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 provided an update on its on-going clinical trial of levosimendan.
Tenax is conducting a multi-center, double-blind, placebo-controlled Phase 2 trial 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 Company has activated all 16 sites which it believes will be sufficient to fully enroll the trial. 24 patients, up from 15 at the end of October, are currently enrolled, out of the targeted 36 patients. Given the current pace of patient enrollment, we expect full enrollment in the first quarter of 2020 with top-line data in the first half of 2020.
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. 24 of 28 patients, approximately 86%, achieved this predefined responder criterion.
Invasive exercise hemodynamic measurements from 22 enrolled patients showed statistically significant improvements during the open-label lead-in phase when compared to baseline, including an average reduction of 7.6 mmHg PCWP, an average reduction in pulmonary arterial pressure (mPAP) of 4.9mmHg, an average reduction in right atrial pressure (RAP) of 5.2 mmHg, and an average increase in cardiac output (CO) of 0.8 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There have been no drug-related serious adverse events, and no patients have withdrawn from the study. 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.
“We are pleased that enrollment rates have been consistently increasing and initial responses continue to exceed our expectations,” said Tony DiTonno, CEO of Tenax Therapeutics. “We anticipate completing this trial in the months to come and quickly moving forward to the next phase of our development efforts to make levosimendan available to those patients suffering from this debilitating disease.”
About Tenax Therapeutics
Tenax Therapeutics, Inc., is a specialty pharmaceutical company focused on identifying, developing and commercializing 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 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). For more information, visit www.tenaxthera.com.
Levosimendan is a calcium sensitizer that works through a unique triple mechanism of action. It initially was developed for intravenous use in hospitalized patients with acutely decompensated heart failure. It was discovered and developed by Orion Pharma, Orion Corporation 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 commercialize levosimendan from Phyxius Pharma, Inc.
Caution Regarding Forward-Looking Statements
This news release contains certain forward-looking statements by the Company that involve risks and uncertainties and reflect the Company’s judgment as of the date of this release. The forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to matters beyond the Company’s control that could lead to delays in the clinical study, new product introductions and customer acceptance of these new products; matters beyond the Company’s control that could impact the Company’s continued compliance with Nasdaq listing requirements; the impact of management changes on the Company’s business and unanticipated charges, costs and expenditures not currently contemplated that may occur as a result of management changes; and other risks and uncertainties as described in the Company’s filings with the Securities and Exchange Commission, including in its annual report on Form 10-K filed on April 1, 2019, its quarterly report on Form 10-Q filed on November 14, 2019 as well as its other filings with the SEC. The Company disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. Statements in this press release regarding management’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.