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 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).
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 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).
Adverse Events
There have been no drug-related serious adverse events, and only 2 patients did not complete the 6 week study. All of the patients who completed the 6-week double-blind phase of the trial have elected to enroll in the open-label extension study.
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 advisory 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.
About Levosimendan
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 March 30, 2020 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.
