Shares of nano-cap Tenax Therapeutics Inc TENX, are advancing strongly Tuesday in the wake of a positive clinical readout.
What Happened?
The North Carolina-based company announced positive Phase 2 results for levosimendan for the treatment of patients with pulmonary hypertension and heart failure with preserved ejection fraction.
Levosimendan is a novel, first in class calcium sensitizer/K-ATP activator, which has a three-pronged approach toward regulating cardiac activity.
The company noted that levosimendan demonstrated a statistically significant reduction in pulmonary capillary wedge pressure compared to baseline and placebo, 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 as compared to placebo.
On safety, the company said the incidence of adverse events or serious adverse events 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 five weeks of treatment.
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What's Next?
Tenax believes the results support a Phase 3 trial that will translate into the first approved therapy to treat these patients.
"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," said Anthony DiTonno, CEO of Tenax.
The company also said it 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.
At last check, Tenax shares were soaring 24% to $1.81 after hitting an intra-day high of $2.58.
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