Tenax Therapeutics, Inc. provided patent and clinical program updates for its two lead product candidates, TNX-103 for the treatment of pulmonary hypertension associated with left heart failure (PH-HFpEF), and TNX-201 for the treatment of pulmonary arterial hypertension (PAH). Tenax Therapeutics has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for the subcutaneous administration of levosimendan. The patent, expected to be issued in January 2022, will provide coverage of subcutaneous administration of levosimendan for the treatment of human subjects with health conditions of any kind, and expires at the end of 2039, exclusive of any patent term extension.

The patent will be eligible for term extension. Tenax Therapeutics announced the completion of the transition from intravenous (IV) to oral levosimendan of those patients currently enrolled in the open label extension (OLE) rollover study (TNX-LVO-05), following their enrolment in the Phase 2 HELP trial. These patients with PH-HFpEF, having previously received weekly infusions of levosimendan for up to two years, were able to transition to oral levosimendan in this substudy, to continue treatment.

The substudy was designed to determine the safety and tolerability of oral levosimendan in this population, with a goal of establishing an oral dose that would maintain its efficacy. All patients currently in the OLE study successfully completed the transition substudy without any unexpected safety issues or serious drug related adverse events. In addition, the multiple measures of efficacy of oral levosimendan confirmed it was comparable to or possibly more effective than the weekly IV regimen in this group of patients.

The substudy included patients currently participating in the OLE of the Phase 2 HELP trial, published in May 2021 in the Journal of the American College of Cardiology: Heart Failure. Data from the transition substudy confirms that oral levosimendan, when dosed at 3-4 mg per day, was safe, well-tolerated, and maintained the efficacy of IV levosimendan therapy in PH-HFpEF patients. Tenax Therapeutics has completed the pharmacokinetic (PK) assessment in healthy volunteers of TNX-201 compared to reference imatinib (GLEEVEC) and made important observations about the characteristics of the two formulations.

Based on these observations, Tenax Therapeutics is modifying the TNX-201 formulation to help ensure optimal efficacy and tolerance in the upcoming Phase 3 trial. Therefore, Tenax Therapeutics anticipates starting the Phase 3 trial in PAH in 2H 2022. In preparation for the Phase 3 trial of TNX-201, Tenax Therapeutics also announced that it has selected a large, global CRO partner with worldwide delivery capabilities.

Tenax Therapeutics' CRO has successfully completed over 20 PAH projects, including multiple Phase 3 trials of PAH therapies. Planning efforts are underway, with KOL and site engagement expected to commence early this year. Additionally, Tenax Therapeutics has formed a Scientific Advisory Board (SAB) focused on imatinib, chaired by Dr. Anna Hemnes of Vanderbilt University.

The SAB also includes Dr. Robert Frantz (The Mayo Clinic), Dr. Bradley Maron (Harvard University) and Dr. John Ryan (University of Utah). These internationally renowned scientists have deep experience in clinical trials for PAH as well as translational science in pulmonary vascular disease.