Tenax Therapeutics Announces New U.S. Patent Covering the Use of Levosimendan in Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF)
30 Avril 2024 - 1:30PM
Tenax Therapeutics, Inc. (Nasdaq: TENX), a Phase 3,
development-stage pharmaceutical company focused on identifying,
developing and commercializing products that address cardiovascular
and pulmonary diseases with high unmet medical need, announced
today that the United States Patent and Trademark Office (USPTO)
has granted the Company a patent covering the use of TNX-103 (oral
levosimendan), TNX-102 (subcutaneous levosimendan), TNX-101 (IV
levosimendan), the active metabolites of levosimendan (OR1896 and
OR18955) and various combinations of cardiovascular drugs with
levosimendan when used to improve exercise performance in PH-HFpEF
patients, entitled:
“LEVOSIMENDAN FOR TREATING PULMONARY
HYPERTENSION WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION
(PH-HFpEF).”
“Expanding our intellectual property estate for levosimendan is
a strategic priority for Tenax. We are committed to protecting the
future commercial value of our innovative PH-HFpEF treatment,” said
Chris Giordano, President & Chief Executive Officer of Tenax
Therapeutics. “The important, additional IP protection this patent
provides will help us maximize the value of levosimendan as we seek
to address one of the largest unmet needs in cardiovascular
medicine today.”
This newly issued patent, U.S. Patent No. 11,969,424, provides
protections through December 2040, including expanded IP rights to
the use of oral, subcutaneous, and intravenous (IV) administration
of levosimendan, as well as its active metabolites (OR1896 and
OR1855) for the treatment of PH-HFpEF, at all therapeutic doses.
The patent also provides IP protection for the use of combinations
with various cardiovascular drugs, when used in PH-HFpEF
patients.
The patents covering the use of IV and oral levosimendan for the
treatment of PH-HFpEF rely on key discoveries Tenax Therapeutics
made with the HELP Study, in which levosimendan-treated PH-HFpEF
patients benefited from a statistically significant improvement in
6-minute walk distance of 29 meters (p=0.03) when IV levosimendan
was compared with placebo. Patients who transitioned to the oral
daily formulation after a lengthy treatment with the weekly IV
formulation improved further in this assessment of exercise
tolerance, which is the primary endpoint of the ongoing Phase 3
LEVEL study.
About the Phase 3 LEVEL Study
( NCT05983250 )
The LEVEL Study is a Phase 3, double-blind, randomized,
placebo-controlled study of levosimendan in patients with PH-HFpEF.
Approximately 152 subjects will be randomized in a 1:1 ratio to
receive an oral dose of levosimendan (2 mg/day) or placebo for
Weeks 1 to 4 and 3 mg/day or placebo for Weeks 5 to 12. The primary
outcome measure for the study is change in six-minute walk distance
from Baseline to Week 12. All randomized subjects will have the
option to enter the 92-week OLE following the completion of all
study events at Week 12.
About Levosimendan (TNX-101, TNX-102,
TNX-103)
Levosimendan is a unique, potassium ATP channel activator and
calcium sensitizer that affects the heart and vascular system
through multiple mechanisms of action. Initially discovered and
developed by Orion Corporation in Finland, intravenous levosimendan
is approved in 60 countries outside the United States for use in
hospitalized patients with acutely decompensated heart failure.
Results of Tenax Therapeutics’ Phase 2 HELP study of levosimendan
in patients with pulmonary hypertension (PH) with heart failure
with preserved ejection fraction (HFpEF) demonstrated that I.V.
levosimendan produces potent dilation of the central and pulmonary
venous circulations which translates into an improvement in
exercise capacity, a discovery that is the basis of LEVEL, the
Phase 3 investigation of Tenax Therapeutics’ potential
groundbreaking therapy. To date, no other drug therapy has improved
exercise tolerance in patients with PH associated with HFpEF, “a
growing epidemic with high morbidity and mortality and no
treatment. The clear unmet need and lethal nature of PH-HFpEF must
be met with novel solutions at all levels of therapeutic
development” (AHA Scientific Advisory, “A Call to Action,”
2022).
About Tenax Therapeutics
Tenax Therapeutics, Inc. is a Phase 3, development-stage
pharmaceutical company focused on identifying, developing, and
commercializing products that address cardiovascular and pulmonary
diseases with high unmet medical need. The Company owns global
rights to develop and commercialize levosimendan, which it has
prioritized in the near term. Tenax Therapeutics also may resume
developing its unique oral formulation of imatinib. For more
information, visit www.tenaxthera.com. Tenax Therapeutics’ common
stock is listed on The Nasdaq Stock Market LLC under the symbol
“TENX”.
Caution Regarding Forward-Looking
Statements
Except for historical information, all of the statements,
expectations and assumptions contained in this press release are
forward-looking statements. These forward-looking statements may
include information concerning possible or projected future
business operations. Actual results might differ materially from
those explicit or implicit in the forward-looking statements.
Important factors that could cause actual results to differ
materially include: our ability to raise additional money to fund
our operations for at least the next 12 months as a going concern;
risks related to our business strategy, including the
prioritization and development of product candidates; intellectual
property risks; risks of our clinical trials, including, but not
limited to, the timing, delays, costs, design, initiation,
enrollment, and results of such trials; any delays in regulatory
review and approval of product candidates in development; reliance
on third parties, including Orion Corporation, our manufacturers
and CROs; risks regarding the formulation, production, marketing,
customer acceptance and clinical utility of our product candidates;
our estimates regarding the potential market opportunity for our
product candidates; the potential advantages of our product
candidates; our competitive position; risks related to our
continued listing on Nasdaq; our ability to maintain our culture
and recruit, integrate and retain qualified personnel and advisors,
including on our Board of Directors; volatility and uncertainty in
the global economy and financial markets in light of the
possibility of pandemics, global financial and geopolitical
uncertainties, including in the Middle East and the Russian
invasion of and war against the country of Ukraine; changes in
legal, regulatory and legislative environments in the markets in
which we operate and the impact of these changes on our ability to
obtain regulatory approval for our products; and other risks and
uncertainties set forth from time to time in our SEC filings. Tenax
Therapeutics assumes no obligation and does not intend to update
these forward-looking statements except as required by law.
Contacts:
Investor Contact:John FrauncesManaging DirectorLifeSci Advisors,
LLCC: 917-355-2395, or
Brian MullenLifeSci Advisors, LLCC: 203-461-1175
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