TENX - Tenax Reports Publication of Phase 2 HELP Study to Evaluate Patients with Pulmonary Hypertension and Heart Failure

Tenax Therapeutics, Inc. (NASDAQ: TENX) announced positive data from its Phase 2 HELP Study that evaluated levosimendan in patients with pulmonary hypertension and heart failure with preserved ejection fraction.  Levosimendan Improves Hemodynamics and Exercise Tolerance in PH-HFpEF: Results of the Placebo-Controlled HELP Trial was published in the Journal of American College of Cardiology: Heart Failure.

The publication had a 84% responder rate during the open label phase as 37 or 44 patients met responder criteria and were randomized to levosimendan (n=18) or placebo (n=19).  Levosimendan did not significantly reduce the primary endpoint of exercise-PCWP but has reduced PCWP measured across all exercise stages.  The 6 week study design utilized invasive cardiovascular hemodynamics and secondary clinical endpoints that include a 6 minute walk test.

Dr. Daniel Burkhoff, MD PhD, Director of Heart Failure, Hemodynamics and Mechanical Circulatory Support Research at Cardiovascular Research Foundation led the blinded hemodynamic core lab and analysis for the HELP trial and is the first author on the publication. Dr. Burkhoff stated “The cardiovascular hemodynamic effects seen in this trial following levosimendan administration were impressive, especially in the first 24 hours. The reductions in cardiac filling pressures and associations with improved exercise performance are important early markers of clinical benefit and signify meaningful improvements in the wellbeing of PH-HFpEF patients. Levosimendan has the potential to have a major impact on the treatment of PH-HFpEF.”

Dr. Stuart Rich, Chief Medical Officer at Tenax Therapeutics and Principal Investigator of the study stated “PH-HFpEF, which is Group 2 Pulmonary Hypertension, is a progressive and fatal disease with no effective medical treatments. Previous attempts to identify an effective treatment from clinical trials using approved pulmonary vasodilators have all failed. This is the first multi-center, randomized, placebo-controlled trial in PH-HFpEF patients to report a statistically significant improvement in 6-minute walk distance. Levosimendan has unique pulmonary vascular and cardiovascular properties which we identified as central to its clinical efficacy. The fact that 84% of the patients enrolled in the initial lead-in phase had a significant hemodynamic response at rest and with exercise during cardiac catheterization provides confidence that levosimendan may be an important treatment for these patients who have a large unmet need.”

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