Attached files
Exhibit
99.2
Tenax Therapeutics Completes Enrollment in Phase 2 Pulmonary
Hypertension Trial
●
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
Morrisville, NC – March 12, 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.
Contacts
Investor
Contact:
Westwicke,
an ICR Company
Stephanie
Carrington, 646-277-1282
Stephanie.carrington@icrinc.com