Tenax Therapeutics Announces Last Patient Completes Final Visit in its Phase 2 “HELP Study” of Levosimendan for Pulmonary...
April 09 2020 - 8:30AM
Business Wire
Top-line Data Readout Remains on Track for
Late Q2 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 the
last patient has completed their final visit in the Company’s Phase
2 clinical trial of levosimendan in patients with pulmonary
hypertension and heart failure with preserved ejection fraction
(PH-HFpEF). The study is also known as the HELP Study (Hemodynamic
Evaluation of Levosimendan in Patients with PH-HFpEF).
- The 36-subject clinical trial began enrollment in late March
2019 and patients were randomized in 10 hospitals across the
U.S.
- Trial finalization leading to data lock and top-line data
readout has now begun.
- Top-line data readout remains on track for late June 2020
PH-HFpEF represents an area of very high unmet medical need.
PH-HFpEF patients suffer from increased mortality as well as a
reduced quality of life. No approved or effective therapies
currently exist to treat the many patients who suffer with
PH-HFpEF.
Tenax CEO Tony Di Tonno stated: “We are thankful for the
dedicated physicians, study coordinators and home health providers
who were able to close out our study with minimal disruption from
the current COVID-19 pandemic crisis. We are continuing to work
very closely with everyone involved in collecting and finalizing
the data required to report top line data before the end of the
second quarter.”
Dr. Stuart Rich, Director of the Pulmonary Vascular Disease
Program at the Bluhm Cardiovascular Institute at Northwestern
University stated, “As a principal investigator who helped to
design and execute the HELP Study, I am eagerly looking forward to
seeing the results of the HELP Study. Based on the remarkably
favorable response reported by investigators during the open label
pre-randomization phase of the trial, I am hopeful the results of
the randomized double-blind phase of the trial will demonstrate
that levosimendan could represent a breakthrough therapy for
PH-HFpEF patients.”
About Phase 2 HELP Study
The HELP Study is a multi-center, double-blind,
placebo-controlled Phase 2 clinical trial designed to evaluate
levosimendan in patients with pulmonary hypertension and heart
failure with preserved ejection fraction (PH-HFpEF).
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 was 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, approximately 84%, achieved this predefined responder
criterion. Investigator reported invasive exercise hemodynamic
measurements from 35 evaluable patients showed statistically
significant improvements during the open-label lead-in phase when
compared to baseline, including an average reduction of 7.8 mmHg
PCWP, an average reduction in pulmonary arterial pressure (mPAP) of
4.8mmHg, an average reduction in right atrial pressure (RAP) of 5.3
mmHg, and an average increase in cardiac output (CO) of 0.4
liters/min. All of these open-label lead-in phase hemodynamic
improvements, with the exception of cardiac output, achieved
statistical significance (P≤0.001, paired t-Test).
Adverse Events
There have been no drug-related serious adverse events, and only
2 patients did not complete the 6 week study. All of the patients
who 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 advisory
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 March 30, 2020
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/20200409005099/en/
Investor Contact: ICR Stephanie Carrington, 646-277-1282
Stephanie.carrington@icrinc.com
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