Full Press Release Details
Therapeutics Reports Positive Results from Phase 2 Trial of
Levosimendan in Patients with Pulmonary Hypertension and Heart
Failure with Preserved Ejection Fraction (PH-HFpEF)
Demonstrated a significant reduction in right atrial and
pulmonary capillary wedge pressures
Demonstrated a significant improvement with 6-minute walk
No significant safety issues.
Management to host conference call and webcast today at
Morrisville, NC June 2, 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 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
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.
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)
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.
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.
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
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.
2, 2020 at 8:30 a.m. EDT
Audio Only Dial-in: (877) 407-9124 (United States) or (201)
689-8584 (International)
Toll Free: 877-481-4010 (United States)/International:
replay available until June 16, 2020
Webcast with Audio: https://www.webcaster4.com/Webcast/Page/2404/35158.
reply available until September 30, 2020.
join the conference call at least 10 minutes early to
A replay of the conference call will be archived under
relations section of
Tenax's website for 30 days shortly after the
About Phase 2 HELP Trial
HELP Trial Hemodynamic Evaluation of Levosimendan in
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