Business
Tenax Announces Publication Titled “Levosimendan Improves Hemodynamics and Exercise Tolerance in PH-HFpEF: Results of the Randomized Placebo-Controlled HELP Trial ”
84% of PH-HFpEF patients responded to levosimendan based on prespecified criteria in the initial open-label lead-in phase Levosimendan improved
About this update from Tenax Therapeutics, Inc.
[{"type":"text","content":"\n\n84% of PH-HFpEF patients responded to levosimendan based on prespecified criteria in the initial open-label lead-in phase \n\n\nLevosimendan improved cardiovascular hemodynamics and exercise capacity in PH-HFpEF patients \n\n\nLevosimendan produced a significant improvement in 6-minute walk distance and is the only therapy to produce such a result in a randomized, double-blind, placebo-controlled trial of PH-HFpEF patients \n\n\nLevosimendan was well tolerated in PH-HFpEF patients\n\n\n MORRISVILLE, N.C.--(BUSINESS WIRE)--\nTenax Therapeutics, Inc. (Nasdaq: TENX), a specialty pharmaceutical company focused on identifying and developing therapeutics that address cardio-pulmonary diseases with high unmet medical need, today announced the publication of positive data from the company’s Phase 2 HELP Study that evaluated levosimendan in patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF). The new publication is titled Levosimendan Improves Hemodynamics and Exercise Tolerance in PH-HFpEF: Results of the Placebo-Controlled HELP Trial and was published in the Journal of American College of Cardiology: Heart Failure (https://www.jacc.org/doi/pdf/10.1016/j.jchf.2021.01.015).\n\nThe HELP (Hemodynamic Evaluation of Levosimendan in PH-HFpEF) Study was designed as a randomized placebo-controlled trial to evaluate the hemodynamic and clinical effects of weekly levosimendan IV infusions in PH-HFpEF patients. This 6-week study design evaluated invasive cardiovascular hemodynamics as well as secondary clinical endpoints including a 6-minute walk test.\n\nResults reported in the publication include an impressive responder rate of 84% during the open-label phase as 37 of 44 patients met responder criteria and were randomized to levosimendan (n=18) or placebo (n=19). Compared with placebo, levosimendan did not significantly reduce the primary endpoint of exercise-PCWP (-1.4 mmHg, 95% CI -7.8, 4.8, p=0.65), but effectively reduced PCWP measured across all exercise stages (-3.9±2.0 mmHg, p=0.047). Levosimendan treatment resulted in a 29.3 meter (95% CI [2.5, 56.1], p=0.033) improvement in 6 MWD compared to placebo. The authors concluded that further study of levosimendan in PH-HFpEF patients is warranted since levosimendan is the first drug to demonstrate improved cardiovascular hemodynamics and a sta...