Tenax Therapeutics (NASDAQ:TENX) reported positive results from a Phase 2 trial evaluating levosimendan for the treatment of patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF).
In the 37-patient study, levosimendan demonstrated a statistically significant reduction in pulmonary capillary wedge pressure from baseline when measurements from patients at rest, with their legs up and on exercise were combined. The drug candidate also demonstrated a statistically significant improvement in six-minute walk distance, compared with placebo.
The company noted that Levosimendan did not demonstrate a statistically significant reduction in pulmonary capillary wedge pressure from baseline on exercise, compared to placebo.
“Levosimendan is the first drug to ever show a favorable mechanism of action with biventricular effects in patients with PH-HFpEF,” Dr. Stuart Rich, a member of Tenax’s scientific advisory board, said in a statement.
“The consistency of the hemodynamic data and improvement in six-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,” he added.
