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October 13, 2022 — Tenax Therapeutics, Inc., a specialty pharmaceutical company focused on identifying, developing, and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, announces the presentation of positive data from a study of PH-HFpEF patients being treated with oral levosimendan. The data, collected during the transition from intravenous (IV) to oral levosimendan in the open-label extension (OLE) of the HELP (Hemodynamic Evaluation of Levosimendan in PH-HFpEF) trial, was presented at the Heart Failure Society of America (HFSA) Scientific Sessions 2022, held from October 1 –3, 2022.
Title: “The Transition from Chronic Intravenous to Oral Levosimendan Is Safe and Effective in Patients with Pulmonary Hypertension with Heart Failure and Preserved Ejection Fraction”
Author: Thenappan Thenappan, MD Associate Professor of Medicine and Section Leader, Pulmonary Hypertension Program at the University of Minnesota, et al.
This substudy of 18 PH-HFpEF patients who transitioned from IV to oral levosimendan, included an evaluation of safety and efficacy across several measures. As compared with the patient’s baseline (on IV levosimendan), the mean change in resting heart rate was 4.9 (SD 7.5) beats/min, the mean systolic arterial blood pressure was 4.1 (SD 12.6) mm Hg, the mean change in 6-minute walk distance (6MWD) (n=17) was 13.1 (SD 39.5) meters, BNP (n=8) was -133.3 (SD 136.6) pg/dl, and NT-proBNP (n=7) was -239.4 (SD 548.1) pg/dl. The mean Kansas City Cardiomyopathy Questionnaire scores (KCCQ-TS, KCCQ-CS and KCCQ-OS) (n=16) improved by 4.7, 2.5 points and 3.7 points, respectively.
The authors concluded that the levosimendan oral formulation was well tolerated without safety concerns over a 6-8-week period in patients with PH-HFpEF who received IV levosimendan for an average of 18 months. There were no serious adverse events (SAEs) related to oral levosimendan therapy. Oral levosimendan was associated with further numerical improvements in 6MWD, BNP/NT-ProBNP, and all key KCCQ domains (encompassing physical symptoms, functional limitation, quality of life, and social function), suggesting oral levosimendan at 3-4 mg/day may provide a superior formulation for chronic use in PH-HFpEF patients when compared to the intravenous administration of levosimendan.
Dr. Stuart Rich, Chief Medical Officer of Tenax Therapeutics, stated, “This important finding confirms that these patients with advanced PH-HFpEF can be treated successfully with daily oral levosimendan while avoiding the risks associated with weekly IV treatments. We are very encouraged to see these effects in patients who have received levosimendan therapy for over two years.”
Tenax Therapeutics’ Chief Executive Officer, Chris Giordano, stated, “The observed safety and effectiveness supports the use of oral levosimendan in Phase 3 testing in patients with PH-HFpEF, a devastating disease with no effective treatment options available. We are grateful to the patients and their families, our investigators, and all the research staff who continue participating in this open label extension.”
The Phase 2 HELP Study of levosimendan, initiated in 2019, enrolled patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF) and was the first clinical trial to show an improvement in exercise capacity in this group of patients with WHO Group 2 pulmonary hypertension (PH associated with left heart disease). Patients who completed HELP and enrolled in the open-label extension study were offered the opportunity to transition from weekly IV infusions to daily oral tablets. The IV-to-oral transition substudy tested the hypothesis that stable dosing – a daily oral formulation rather than a weekly IV infusion – would not only eliminate the risk of IV-related line infections and thrombosis, but would safely retain the observed efficacy of IV levosimendan.
For more information: https://tenaxthera.com/
April 16, 2024 
