Phase 3 Trial Begins: Tenax's TNX-103 for PH-HFpEF

Tenax Therapeutics, a pharmaceutical firm dedicated to addressing significant unmet needs in cardiovascular and pulmonary diseases, has announced the commencement of their Phase 3 clinical trial, known as the LEVEL Study. The study, which stands for "LEVosimendan to Improve Exercise Limitation in PH-HFpEF Patients," has enrolled its first participant. This marks a significant step forward in the development of a potential new treatment for pulmonary hypertension in heart failure patients with preserved ejection fraction (PH-HFpEF), a condition for which no FDA-approved drugs currently exist.

The LEVEL Study is a randomized, double-blind, placebo-controlled trial that will involve 152 patients. It is designed to assess the efficacy of an oral formulation of levosimendan, a drug that has shown promise in improving exercise capacity in patients with PH-HFpEF. The primary endpoint of the study will be the six-minute walking distance, a measure used to evaluate the functional capacity of patients with heart and lung diseases. The trial will run for 12 weeks, with patients initially receiving a dose of 2 mg/day for the first four weeks, followed by 3 mg/day for the subsequent eight weeks.

The study is being conducted in collaboration with leading research centers across North America, many of which have previously participated in Tenax Therapeutics' research. The company's Chief Medical Officer, Dr. Stuart Rich, highlighted the enthusiasm among medical experts for the novel mechanism of action of levosimendan and the potential it holds for treating PH-HFpEF.

Tenax Therapeutics holds the North American rights to develop and commercialize various formulations of levosimendan, including intravenous, subcutaneous, and oral forms. The company has an extensive patent estate for levosimendan, which provides protection for the proprietary oral formulation being tested in the LEVEL Study through at least 2040.

The Phase 3 trial is a critical step in the development of TNX-103, the oral formulation of levosimendan, which could offer a new approach to treating PH-HFpEF. The FDA has not required a long-term cardiovascular outcomes trial for this population, which simplifies the registration process for TNX-103 and reduces associated costs and time.

Levosimendan is a unique drug that activates potassium ATP channels and sensitizes calcium in the heart and vascular system. It was initially developed by Orion Corporation and is approved in 58 countries outside the United States for treating acutely decompensated heart failure. The drug has demonstrated the ability to dilate central and pulmonary venous circulations, leading to improved exercise capacity in patients with PH-HFpEF.

Tenax Therapeutics is committed to advancing the development of innovative therapies for cardiovascular and pulmonary diseases. The company is also developing an oral formulation of imatinib, further expanding its pipeline of potential treatments for unmet medical needs.

The first patient's enrollment in the LEVEL Study is a significant milestone for Tenax Therapeutics and represents a step towards providing a new treatment option for patients suffering from PH-HFpEF. The study's results are expected to be available in the second half of 2025, offering hope for a breakthrough in the management of this challenging condition.