Tenax Therapeutics Completes Enrollment in Phase 2 Pulmonary Hypertension Trial
March 12 2020 - 8:30AM
Business Wire
- 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
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.
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 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). 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 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20200312005105/en/
Westwicke, an ICR Company Stephanie Carrington, 646-277-1282
Stephanie.carrington@icrinc.com
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