- Demonstrated a significant reduction
in right atrial and pulmonary capillary wedge pressures
- Demonstrated a significant improvement
with 6-minute walk distance
- No significant safety issues.
- Management to host conference call and
webcast today at 8:30 a.m. EDT
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 positive
Phase 2 results for levosimendan for the treatment of patients with
pulmonary hypertension and heart failure with preserved ejection
fraction (PH-HFpEF). In this 37 patient study, the primary efficacy
analysis, pulmonary capillary wedge pressure (PCWP) during exercise
did not demonstrate a statistically significant reduction from
baseline. Levosimendan did demonstrate a statistically significant
reduction in PCWP compared to baseline (p=<0.0017) and placebo
(p=<0.0475)when the measurements at rest, with legs up and on
exercise were combined. Levosimendan also demonstrated a
statistically significant improvement in 6-minute walk distance
(6MWD) as compared to placebo (p=0.0329).
Dr. Stuart Rich, Professor of Medicine at the Bluhm
Cardiovascular Institute at Northwestern University commented
“Levosimendan is the first drug to ever show a favorable mechanism
of action with biventricular effects in patients with PH-HFpEF. The
consistency of the hemodynamic data and improvement in 6-minute
walk demonstrates that levosimendan has great promise as a
treatment for PH-HFpEF which has a serious unmet need. The
favorable safety profile, especially the absence of any
proarrhythmic effects, supports the further development with a
phase 3 trial.”
Hemodynamic Results
Hemodynamic measurements were made at rest (supine), after leg
raise on a supine bicycle (a test of rapid increase in ventricular
filling) and during exercise (25 watts for 3 minutes or until the
patient tired). Levosimendan demonstrated a statistically
significant reduction in PCWP compared to baseline (p=<0.0017)
and placebo (p=<0.0475) when the measurements at rest, with legs
up and on exercise were combined. While there was no significant
change in PCWP during exercise, patients receiving levosimendan had
reductions from baseline at Week 6 in PCWP, pulmonary artery
pressure (PAP), and right atrial pressure (RAP) that were
significant when patients were “at rest” and/or with their “legs
raised” (p<0.05).
Clinical Results (6 Minute Walk Distance)
The clinical efficacy was confirmed by a statistically
significant improvement in 6-minute walk distance of 29 meters.
(p=0.0329). The 6-minute walk distance was a secondary endpoint in
the trial and is a validated and accepted endpoint used in many
pulmonary hypertension registration trials. Levosimendan was given
in once-weekly home infusions for 6 weeks.
Safety
The incidence of AEs or SAEs between the control and treated
groups were similar. In addition, there were no arrhythmias
observed, atrial or ventricular, when comparing baseline
electrocardiographic monitoring with 72-hour monitoring after 5
weeks of treatment. The company plans to present the full study
results at future medical meetings and will submit a full
manuscript of the trial results to a peer-reviewed journal.
"The positive outcome of this Phase 2 trial represents a major
milestone for Tenax and our development of levosimendan for the
treatment of patients suffering from this debilitating illness,”
stated Anthony DiTonno, Chief Executive Officer of Tenax. "It is
particularly exciting to report these positive results that support
our confidence that levosimendan’s unique pharmacologic profile and
mechanism of action may be ideally suited to treat PH-HFpEF. We
believe these results support a Phase 3 trial that will translate
into the first approved therapy to treat these patients.”
Conference Call & Webcast Information
The Tenax Therapeutics management team will host a conference
call and live webcast with slides with the investment community
today, Tuesday, June 2, 2020, at 8:30 a.m. EDT to discuss the
information in this press release. Dr. Stuart Rich, Professor of
Medicine at the Bluhm Cardiovascular Institute at Northwestern
University will join the call.
When: June 2, 2020 at 8:30 a.m. EDT
Audio Only Dial-in: (877) 407-9124 (United States) or
(201) 689-8584 (International)
Replay: Toll Free: 877-481-4010 (United
States)/International: 919-882-2331
Replay Passcode: 35158
Audio replay available until June 16,
2020
Webcast with Audio:
https://www.webcaster4.com/Webcast/Page/2404/35158.
Webcast reply available until September 30,
2020.
Please join the conference call at least 10 minutes early to
register.
A replay of the conference call will be archived under the
investor relations section of Tenax's website for 30 days shortly
after the call.
About Phase 2 HELP Trial
The HELP Trial – Hemodynamic Evaluation of Levosimendan in
PH-HFpEF is a multi-center, double-blind, placebo-controlled Phase
2 clinical trial designed to evaluate levosimendan in 36 patients
with pulmonary hypertension and heart failure with preserved
ejection fraction (PH-HFpEF). 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. The primary endpoint of the HELP
Trial is based on change in PCWP vs baseline compared to
placebo.
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 has recently released topline data regarding 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, and its quarterly report of Form 10-Q filed on May 15, 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20200602005359/en/
Investor Contact: ICR Stephanie Carrington, 646-277-1282
Stephanie.carrington@icrinc.com
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