Tenax Therapeutics Announces FDA Clearance of IND for TNX-103 (oral levosimendan) for the Treatment of Pulmonary Hypertension with Heart Failure with Preserved Ejection Fraction (PH-HFpEF), Initiation of Phase 3 sites expected 2023
13 Novembre 2023 - 2:30PM
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, announced today that the U.S. Food and
Drug Administration (FDA) has reviewed and cleared the Company’s
Investigational New Drug (IND) Application for TNX-103 (oral
levosimendan) for the treatment of pulmonary hypertension with
heart failure with preserved ejection fraction (PH-HFpEF), enabling
Tenax to proceed with the first of two Phase 3 studies.
The LEVEL Study (LEVosimendan to Improve
Exercise Limitation in PH-HFpEF
Patients) is expected to launch in the fourth quarter of 2023.
“We could not be more pleased with the results of our
collaborative, productive discussions with the FDA, which provide a
clear path to starting LEVEL, including mutual alignment with
respect to the primary efficacy endpoint and expected patient
enrollment,” said Chris Giordano, President and Chief Executive
Officer of Tenax Therapeutics. “Importantly, Tenax will not be
required to conduct a long-term, cardiovascular outcomes trial,
which should significantly reduce our costs and time to
registration for TNX-103. With no approved therapies currently
available in the U.S., physicians, patients and regulators
increasingly recognize the significant unmet need of patients who
suffer from PH-HFpEF.”
“Despite many therapeutic advancements across a wide spectrum of
cardiovascular diseases, there are no FDA-approved treatments for
PH-HFpEF, a condition impacting millions globally,” said Sanjiv
Shah, MD, Stone Professor and Director of the HFpEF Program at
Northwestern University Feinberg School of Medicine, and Chair of
the LEVEL Steering Committee. “I am pleased to be leading this
important new trial investigating TNX-103, which is designed to
help advance our understanding of how K+ATP activation may provide
a new approach for reducing the high central and venous blood
pressures frequently associated with PH-HFpEF.”
“Based on its unique properties as a K+ ATP channel activator,
coupled with the proof-of-concept data from the Phase 2 HELP study,
TNX-103 has mechanistic potential to address the underlying
pathophysiology of PH-HFpEF,” said Stuart Rich, M.D., Chief Medical
Officer of Tenax Therapeutics. “We expect oral levosimendan will
provide consistent drug concentration levels, supporting improved
efficacy, as observed in patients who transitioned from weekly IV
to oral therapy following the HELP study.”
Tenax Therapeutics and its CRO partner have already selected
more than two-thirds of the research sites targeted to participate
in the LEVEL Study, including many of the leading cardiovascular
centers in the United States and Canada. Every investigative site
that enrolled patients in the HELP Study has been invited to
participate in LEVEL, and already 90% have agreed to take
part.
About Levosimendan (TNX-101, TNX-102, and
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 58 countries outside the United States for use in
hospitalized patients with acutely decompensated heart failure.
Tenax Therapeutics has North American rights to develop and
commercialize IV (TNX-101), subcutaneous (TNX-102), and oral
(TNX-103) formulations of levosimendan. Results of Tenax
Therapeutics’ Phase 2 HELP trial of levosimendan in patients with
pulmonary hypertension (PH) and heart failure with preserved
ejection fraction (HFpEF) demonstrated that IV levosimendan
produces potent dilation of the central and pulmonary venous
circulations which translates into an improvement in exercise
capacity, a discovery that forms the basis for 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 Imatinib (TNX-201)
Tenax Therapeutics is developing novel dosing and a unique
formulation of imatinib mesylate, a kinase inhibitor that has
received FDA’s orphan designation (March 2020) for the treatment of
pulmonary arterial hypertension (PAH). The IMPRES trial, a previous
Phase 3 trial, demonstrated that oral imatinib may produce a
markedly greater, and much more durable, treatment effect on
exercise tolerance, than any other available PAH treatment, alone
or in combination, based on the results observed in those patients
who were maintained on the full imatinib dose for the majority of
the trial. Despite the availability of several classes of pulmonary
vasodilators, no existing treatment has been shown to halt
progression or induce regression of the disease. Imatinib acts on
underlying cellular proliferative pathways associated with PAH and
has the potential to be approved as a disease modifying therapy for
PAH.
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 owns North American rights to develop and
commercialize subcutaneous and oral formulations of levosimendan.
Tenax Therapeutics also is developing a unique oral formulation of
imatinib. For more information, visit www.tenaxthera.com.
Tenax’s 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. 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: risks related to our business strategy,
including the prioritization of product candidates; risks of our
clinical trials, including, but not limited to, the timing, delays,
costs, design, initiation, enrollment, and results of such trials;
our ability to raise additional money to fund our operations for at
least the next 12 months as a going concern; 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; intellectual property risks; 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 COVID-19
pandemic or similar health epidemics and geopolitical uncertainties
such as in 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 MullalyManaging DirectorLifeSci Advisors,
LLCC: 617-429-3548
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