Tenax Therapeutics, Inc. (TENX) Discusses Phase III LEVEL Trial Results for Oral Levosimendan in HFpEF Patients Transcript

Operator

Good day, and welcome to the Tenax Therapeutics Phase 3 LEVEL Topline Results Conference Call. [Operator Instructions] Please note this event is being recorded. I would now like to turn the conference over to Chris Giordano, President and Chief Executive Officer. Please go ahead.

Christopher Giordano
CEO, President & Director

Good morning, everyone. Thank you, Betsy. Thank you, everyone, for joining us. I’m Chris Giordano, President and Chief Executive Officer of Tenax Therapeutics. This morning, we released topline results from LEVEL, our first Phase 3 trial of oral levosimendan in patients with PH-HFpEF. The primary endpoint did not reach statistical significance. The difference between groups in 6-minute walk distance at week 12 was 3.5 meters with a p-value of 0.63. But the evidence we will share with you today impresses us.

Levosimendan’s impact on key objective biological targets directly translates benefit from pulmonary pressure and BNP lowering to functional improvement in the more advanced patients we treated. We believe we have a drug for the many patients who need it, and there are millions of them around the world. Our Phase 2 HELP results found a new target population for this unique drug. LEVEL was always intended to validate the efficacy shown in that study, more precisely measure the treatment effect and establish the right patients who benefit in this very heterogeneous HFpEF population.