- 15 patients have been randomized
- 83% initial response rate to qualify for randomization
- Pulmonary capillary wedge pressure (PCWP) was reduced , on average, by 8 mmHg during exercise following the initial levosimendan infusion
- No serious drug-related adverse events have been reported to date
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.
Enrollment Update
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 of its anticipate 15 sites which it believes will be sufficient to fully enroll the trial. 15 patients, up from eight at the end of August, are currently enrolled, out of the targeted 36 patients. Given the current pace of patient enrollment, we continue to expect full enrollment and top-line data in the first quarter of 2020.
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 that PCWP measured during supine exercise is ≥ 4mmHg less after the open-label infusion than at baseline. 15 of the 18 patients, approximately 83%, achieved this predefined responder criterion with a mean reduction of 8 mmHg in PCWP.
Adverse Events
There have been no drug-related serious adverse events, and no patients have withdrawn from the study.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.
Tenax CEO Tony DiTonno stated, “We are excited to provide this interim update regarding the HELP Study enrollment and preliminary responder information. While these open-label hemodynamic responses are preliminary, it is encouraging to see such favorable responses. We are very fortunate to have so many prominent investigators and leading academic centers participating in the HELP Study.”
Dr. Stuart Rich, Director of the Pulmonary Vascular Disease Program at the Bluhm Cardiovascular Institute at Northwestern University and the principal investigator and architect for the HELP Study stated, “The high initial response rate, and the magnitude of the initial response with exercise has exceeded my expectations. I remain very hopeful that we may have an effective treatment for PH-HFpEF for the first time.”
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.
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 April 1, 2019, its quarterly report on Form 10-Q filed on August 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.
Contacts
Investor Contact:
ICR
Stephanie Carrington, 646-277-1282
Stephanie.carrington@icrinc.com