Tenax Therapeutics enrolls first patient in phase 3 trial for pulmonary hypertension treatment
Betsy Goodfellow | February 8, 2024 | News story | Research and Development | Cardiology, Tenax Therapeutics, clinical trial, pulmonary hypertension
Tenax Therapeutics has announced that it has enrolled the first patient in its phase 3 LEVEL study, which aims to assess TNX-103 (oral levosimendan) for the treatment of pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF).
The trial’s primary endpoint will evaluate six-minute walking distance (6MWD) and will enroll approximately 152 patients, who will be randomised in a 1:1 ratio to either receive either an oral dose of levosimendan or placebo.
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 enroll 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.”
Betsy Goodfellow
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