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.
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).
Caution Regarding Forward-Looking Statements
This news release contains certain forward-looking statements by the Company that involve risks and uncertainties and reflect the Company’s judgment as of the date of this release. The forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to matters beyond the Company’s control that could lead to the Company’s need for additional funding to continue to operate as a going concern; risks associated with the Company’s ability to manage operating expenses and obtain additional capital as needed; the impact of significant reductions in the Company’s operations on its ability to develop its product candidates or maintain compliance with laws and regulations relating to public companies; the Company’s ability to maintain compliance with Nasdaq’s continued listing standards and policies and to maintain the listing and trading of its common stock on that exchange; uncertainties inherent in the conduct of clinical studies and the risk that the Company’s product candidates may not demonstrate adequate safety, efficacy or tolerability in one or more clinical studies for approval by regulatory authorities; the potential for the Company to sell or license part or all of its assets; the impact of management changes on the Company’s business and unanticipated charges, costs and expenditures not currently contemplated that may occur as a result of management changes; and other risks and uncertainties as described in the Company’s filings with the Securities and Exchange Commission, including in its annual report on Form 10-K filed on March 16, 2017, as well as its other filings with the SEC. The Company disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. Statements in this press release regarding management’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.
Stern Investor Relations, Inc.
Will O‘Connor, 212-362-1200