Tenax Therapeutics, Inc. (NASDAQ: TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products for the critical care market, today reported a comprehensive clinical development update for its lead candidate levosimendan.
Phase 3 LEVO-CTS Trial for Levosimendan in Low Cardiac Output Syndrome (LCOS)
Tenax announced today that it has enrolled 833 patients in the Phase 3 LEVO-CTS trial in cardiac surgery patients. The Company plans to complete the study at an estimated 880 total patients to ensure sufficient powering, and anticipates reaching that total around the end of October based on current enrollment trends.
Tenax also announced that the trial’s Data and Safety Monitoring Board (DSMB) recently completed the final safety review from the first 621 patients enrolled and recommended that the study continue as planned.
Once the Company completes enrollment, follow-up will be conducted on the final patient for 30 days before locking the database to begin the top-line data analysis process. In conjunction with the study’s lead investigators at Duke Clinical Research Institute (DCRI), the Company now expects to release top-line results near the end of 2016, dependent upon enrollment trends during the next month.
“We are now nearing the completion of enrollment for our Phase 3 LEVO-CTS trial in cardiac surgery, our primary indication for levosimendan, and are pleased to have passed the final safety analysis from the DSMB,” said John Kelley, CEO of Tenax Therapeutics. “Sustained execution by our clinical team has allowed us to significantly increase our enrollment rate in 2016, and we are now poised to complete enrollment at an estimated 880 patients around the end of October, to enable a readout of top-line results near the end of this year. We are singularly focused on completing the remainder of this trial and ensuring the highest quality of data, and believe that levosimendan can provide a significant benefit in this critical care population.”
Following top-line data, full results from the study are expected to be presented at a medical meeting during the first half of 2017. If positive, Tenax would anticipate submitting a New Drug Application to the U.S. Food and Drug Administration during 2017.
The LEVO-CTS trial is a double-blind, randomized, placebo-controlled study that is evaluating the use of levosimendan administered before and during cardiac surgery to reduce the incidence of low cardiac output syndrome (LCOS) and associated morbidity and mortality. The trial is also measuring secondary endpoints around potential pharmacoeconomic benefits and the incidence rate of LCOS. The United States Food and Drug Administration (FDA) has granted Fast Track status for levosimendan in this indication, and agreed to the Phase 3 protocol design under Special Protocol Assessment (SPA).
The full LEVO-CTS trial design was recently published by the study’s investigators in the American Heart Journal, in an article titled, “Levosimendan in Patients with Left Ventricular Systolic Dysfunction Undergoing Cardiac Surgery on Cardiopulmonary Bypass: Rationale and Study Design of the LEVO-CTS Trial.”
Levosimendan in Septic Shock
Today, Anthony Gordon, M.D., Chair in Anaesthesia and Critical Care, Imperial College London, also presented results from the LeoPARDS (Levosimendan for the Prevention of Acute Organ Dysfunction in Sepsis) trial evaluating levosimendan in septic shock at the 29th Annual Congress of the European Society of Intensive Care Medicine (ESICM), held in Milan, Italy.
Results presented by Dr. Gordon show that the levosimendan treatment arm did not achieve the trial’s primary endpoint of reducing the incidence and severity of acute organ dysfunction in adult patients who have septic shock, as well as the pre-specified secondary endpoints. Based upon the results seen today, Tenax does not anticipate undertaking further development with levosimendan in the septic shock indication.
“While we have not yet received the data from this study, based on today’s presentation, we do not currently plan to move forward with levosimendan in septic shock,” Kelley continued. “We want to thank lead investigator Dr. Anthony Gordon and Imperial College for undertaking this study and enabling our collaboration to provide this important, efficient clinical answer.”
In August 2014, Tenax announced a collaboration with Imperial College London to provide $500,000 in supplemental funding to support the accelerated enrollment and completion of the trial.
About Tenax Therapeutics
Tenax Therapeutics, Inc., is a specialty pharmaceutical company focused on identifying, developing and commercializing products for the critical care market. The Company owns the North American rights to develop and commercialize levosimendan, 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). For more information, visit www.tenaxthera.com.
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 delays in the clinical study, delays in new product introductions and customer acceptance of these new products, and other risks and uncertainties as described in the company’s filings with the Securities and Exchange Commission, including in its transition report on Form 10-KT filed on March 14, 2016, its quarterly report on Form 10-Q filed on August 9, 2016 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.
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Jesse Baumgartner, 212-362-1200