Tenax Therapeutics Reports Positive Results from Phase 2 Trial of Levosimendan in Patients with Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction (PH-HFpEF)

Nachrichtenquelle: Business Wire (engl.)
02.06.2020, 13:30  |  303   |   |   

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).

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 Tenax Therapeutics Reports Positive Results from Phase 2 Trial of Levosimendan in Patients with Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction (PH-HFpEF) 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 …

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