Tenax Therapeutics Provides Update on Phase 2 Pulmonary Hypertension Clinical Trial
January 13 2020 - 8:30AM
Business Wire
- 24 patients have been randomized
- 86% initial response rate to qualify for randomization
- Pulmonary capillary wedge pressure (PCWP) was reduced, on
average, by 7.6 mmHg during exercise following the initial
levosimendan infusion
- No serious drug-related adverse events have been reported to
date
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 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.
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. 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)
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.
“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.
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/20200113005041/en/
ICR Stephanie Carrington, 646-277-1282
Stephanie.carrington@icrinc.com
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