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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.