Tenax Therapeutics Inc.'s (TENX) phase II trial, which evaluated Levosimendan in patients with pulmonary hypertension and heart failure with preserved ejection fraction, has produced mixed results.
In the study, dubbed HELP, the primary endpoint of the change from baseline Pulmonary capillary wedge pressure (PCWP) with bicycle exercise (25Watts) at week 6 following five weekly infusions of Levosimendan post-randomization did not demonstrate a statistically significant reduction from baseline.
However, Levosimendan did demonstrate a statistically significant reduction in PCWP compared to baseline and placebo when the measurements at rest, with legs up and on exercise, were combined, the Company noted.
The trial also demonstrated a statistically significant improvement in 6-minute walk distance of 29 meters, which was the secondary endpoint - a validated and accepted endpoint in many pulmonary hypertension registration trials.
TENX closed Monday's trading at $1.45, up 0.69%.
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