MORRISVILLE, N.C.--(BUSINESS WIRE)--Tenax Therapeutics, Inc. (NASDAQ: TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products for the critical care market, today provided an update on its recent pre-NDA meeting with the FDA.
Tenax met with the FDA on May 10, 2017 to review additional data analyses from the recently completed Phase 3 LEVO-CTS clinical study of levosimendan in cardiac surgery patients at risk of LCOS. The discussion with the FDA built on previously presented primary data analyses of the LEVO-CTS trial that identified a significant interaction in levosimendan’s effectiveness across surgery types enrolled in the study.
The focus of the meeting concentrated on additional analyses of the 66% of patients in the LEVO-CTS trial who underwent coronary artery bypass grafting (CABG) alone. In this large prespecified subgroup of Isolated CABG patients enrolled in the LEVO-CTS trial, levosimendan treated patients benefited from a highly significant 73% relative risk reduction in all-cause mortality at Day 90, 2.1% levosimendan vs 7.9% placebo treated patients, (p=0.0016). This result is consistent with previous Isolated CABG trials (e.g. Levin, et. al. 2012) which formed the hypothesis for the LEVO-CTS study. In contrast, levosimendan treated patients who underwent any type of valve surgery saw a non-statistically significant increase in 90-day mortality.
In addition to the statistically significant reduction in mortality in the Isolated CABG subgroup, Tenax also presented data showing a substantial improvement in post-operative hemodynamics in Isolated CABG patients treated with levosimendan. These hemodynamic improvements included highly statistically significant differences in post-operative cardiac index and reduction in low cardiac output syndrome in Isolated CABG patients treated with levosimendan vs placebo. The observed 46% relative risk reduction in the incidence of low cardiac output syndrome (LCOS) in the LEVO-CTS Isolated CABG patients treated with levosimendan was highly statistically significant (p=0.0014). This is a noteworthy finding since LCOS was a secondary endpoint in the LEVO-CTS trial and patients who experience LCOS have a much higher incidence of death and morbidities following cardiac surgery. Similar signs of positive hemodynamic response were not observed in levosimendan treated patients undergoing valve surgery in the LEVO-CTS trial.
Tenax also presented support from other published trials of levosimendan in cardiac surgery and published analyses of results across studies.
“While the initial top-line results of the LEVO-CTS study were disappointing, this additional analysis confirmed that CABG only patients, a prespecified subgroup of the study composing 66% of all patients enrolled, benefited from statistically significant reductions in both 30 and 90-day mortality rates, post-operative cardiac index and incidence of low cardiac output syndrome (LCOS),” said Michael Jebsen, Interim CEO of Tenax Therapeutics. “We are encouraged to find the data generated from the LEVO-CTS supports our continued belief that levosimendan is an effective and safe inotrope to increase cardiac output in CABG only patients at risk for developing perioperative low cardiac output syndrome.”
According to data for the Society of Thoracic Surgeons (STS) National Database, Isolated CABG Surgery patients represent 68% of all major open heart surgery procedures performed in the US, which equates to 150,000 to 200,000 patients. An analysis of the Premier hospital database indicated approximately 38% of Isolated CABG surgery patients have 2 or more pre-operative risk factors for LCOS.
As a follow-up to the pre-NDA meeting, the FDA requested submission of additional information from published cross study analyses that were presented during the meeting. FDA indicated that they will provide feedback to Tenax as to whether a levosimendan NDA for treatment of coronary bypass surgery patients at risk of LCOS is fileable following their review of the requested information.
About Tenax Therapeutics
Tenax Therapeutics, Inc., is a specialty pharmaceutical company focused on identifying, developing and commercializing products for the critical care market. For more information, visit www.tenaxthera.com.
About Levosimendan
Levosimendan is a calcium sensitizer that works through a unique triple mechanism of action. It initially was developed for intravenous use in hospitalized patients with acutely decompensated heart failure. It was discovered and developed by Orion Pharma, Orion Corporation of Espoo Finland, and is currently approved in over 60 countries for this indication and not available in the United States. Tenax Therapeutics acquired the North American rights to develop and commercialize levosimendan from Phyxius Pharma, Inc. and the United States Food and Drug Administration (FDA) has granted Fast Track status for levosimendan for the reduction of morbidity and mortality in cardiac surgery patients at risk for developing Low Cardiac Output Syndrome (LCOS).
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