Clinical Trials

The trial’s primary endpoint will evaluate six-minute walking distance (6MWD) and will enrol approximately 152 patients, who will be randomised in a 1:1 ratio to either receive either an oral dose of levosimendan or placebo.

According to the company’s press release: ‘The phase 3 programme for TNX-103 has been designed to exceed the minimal clinically important difference, and satisfy the US Food and Drug Administration’s (FDA) request for subject drug exposure of 300 patients for six months and 100 patients for one year (these are minimum requirements per ICH guidelines)’.

Chris Giordano, president and chief executive officer of Tenax Therapeutics, commented: “We are pleased to announce the enrolment of our first patient in the phase 3 LEVEL study, and delighted we are progressing rapidly from identification to initiation of investigator sites. The Tenax team and our CRO and other research partners have worked tirelessly to reach this milestone. Our study is generating enthusiasm among North American cardiologists who treat PH-HFpEF. FDA has approved no drugs, to date, for this disease.”

Stuart Rich MD, chief medical officer of Tenax Therapeutics, added: “We are thrilled to be working with some of the largest, most prestigious cardiovascular research institutes in North America, if not the world. Nine of the ten investigators who randomised patients in our previous levosimendan study – at sites like Mayo, Harvard, Northwestern – have agreed to enrol patients in LEVEL. This reflects a growing interest among these academic medical experts in the novel mechanism of action of levosimendan, and a new approach to this disease.”