MORRISVILLE, N.C.–(BUSINESS WIRE)–Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty pharmaceutical firm targeted on figuring out and growing therapeutics that tackle cardio-pulmonary ailments with excessive unmet medical want, immediately introduced the publication of constructive information from the corporate’s Part 2 HELP Examine that evaluated levosimendan in sufferers with pulmonary hypertension and coronary heart failure with preserved ejection fraction (PH-HFpEF). The brand new publication is titled Levosimendan Improves Hemodynamics and Train Tolerance in PH-HFpEF: Outcomes of the Placebo-Managed HELP Trial and was printed within the Journal of American School of Cardiology: Coronary heart Failure (https://www.jacc.org/doi/pdf/10.1016/j.jchf.2021.01.015).
The HELP (Hemodynamic Evaluation of Levosimendan in PH-HFpEF) Examine was designed as a randomized placebo-controlled trial to judge the hemodynamic and medical results of weekly levosimendan IV infusions in PH-HFpEF sufferers. This 6-week examine design evaluated invasive cardiovascular hemodynamics in addition to secondary medical endpoints together with a 6-minute stroll check.
Outcomes reported within the publication embody a powerful responder price of 84% throughout the open-label section as 37 of 44 sufferers met responder standards and have been randomized to levosimendan (n=18) or placebo (n=19). In contrast with placebo, levosimendan didn’t considerably scale back the first endpoint of exercise-PCWP (-1.4 mmHg, 95% CI -7.8, 4.8, p=0.65), however successfully diminished PCWP measured throughout all train phases (-3.9±2.0 mmHg, p=0.047). Levosimendan therapy resulted in a 29.3 meter (95% CI [2.5, 56.1], p=0.033) enchancment in 6 MWD in comparison with placebo. The authors concluded that additional examine of levosimendan in PH-HFpEF sufferers is warranted since levosimendan is the primary drug to reveal improved cardiovascular hemodynamics and a statistically important enhance in six-minute stroll distance seen in comparison with placebo
Dr. Daniel Burkhoff, MD PhD, Director of Coronary heart Failure, Hemodynamics and Mechanical Circulatory Help Analysis at Cardiovascular Analysis Basis led the blinded hemodynamic core lab and evaluation for the HELP trial and is the primary creator on the publication. Dr. Burkhoff said “The cardiovascular hemodynamic results seen on this trial following levosimendan administration have been spectacular, particularly within the first 24 hours. The reductions in cardiac filling pressures and associations with improved train efficiency are vital early markers of medical profit and signify significant enhancements within the wellbeing of PH-HFpEF sufferers. Levosimendan has the potential to have a significant affect on the therapy of PH-HFpEF.”
Dr. Stuart Wealthy, Chief Medical Officer at Tenax Therapeutics and Principal Investigator of the examine said “PH-HFpEF, which is Group 2 Pulmonary Hypertension, is a progressive and deadly illness with no efficient medical therapies. Earlier makes an attempt to establish an efficient therapy from medical trials utilizing accepted pulmonary vasodilators have all failed. That is the primary multi-center, randomized, placebo-controlled trial in PH-HFpEF sufferers to report a statistically important enchancment in 6-minute stroll distance. Levosimendan has distinctive pulmonary vascular and cardiovascular properties which we recognized as central to its medical efficacy. The truth that 84% of the sufferers enrolled within the preliminary lead-in section had a major hemodynamic response at relaxation and with train throughout cardiac catheterization offers confidence that levosimendan could also be an vital therapy for these sufferers who’ve a big unmet want.”
About Tenax Therapeutics
Tenax Therapeutics, Inc., is a specialty pharmaceutical firm targeted on figuring out, growing, and commercializing merchandise that tackle cardiovascular and pulmonary ailments with excessive unmet medical want. The Firm has a world-class scientific advisory group together with acknowledged world consultants in pulmonary hypertension. The Firm owns North American rights to develop and commercialize levosimendan and has just lately launched topline information concerning their Part 2 medical trial for the usage of levosimendan within the therapy of Pulmonary Hypertension related to Coronary heart Failure and preserved Ejection Fraction (PH-HFpEF). Tenax plans to advance a delayed launch oral formulation of imatinib, designed to keep away from the gastric irritation, right into a single pivotal trial pursuant to the 505(b)(2) pathway. For extra data, go to www.tenaxthera.com.
Levosimendan is a calcium sensitizer and Ok-ATP Channel activator that works by way of a singular mechanism of motion. It initially was developed for intravenous use in hospitalized sufferers with acutely decompensated coronary heart failure. It was found and developed by Orion Pharma, Orion Company of Espoo Finland, and is at the moment accepted in over 60 nations for this indication and never obtainable in the US. Tenax Therapeutics acquired North American rights to develop and commercialize levosimendan from Phyxius Pharma, Inc.
Imatinib is an antiproliferative agent developed to focus on the BCR-ABL tyrosine kinase in sufferers with persistent myeloid leukemia. The inhibitory results of imatinib on PDGF receptors and c-KIT advised that it might be efficacious in PAH. Imatinib reversed experimentally induced pulmonary hypertension and has pulmonary vasodilatory results in animal fashions and proapoptotic results on pulmonary artery clean muscle cells from sufferers with idiopathic PAH. In a section 3 medical trial imatinib produced important enhancements in train capability, however a excessive price of dropouts attributed largely to gastric intolerance prevented regulatory approval.
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