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First Clinical Site Active in Phase 2 Trial as Tenax Therapeutics Aims to Fill Gap in Treatment for Pulmonary Hypertension

As it grows in diagnoses, pulmonary hypertension with preserved ejection fraction (PH-HFpEF) remains woefully underserved, with no FDA-approved drugs to treat the disease. Indeed, there are several options for therapeutics specific to pulmonary arterial hypertension (PAH), but there is a clear differentiation between the two conditions supported by clinical data that what works for PAH does not work for PH-HFpEF.

To that point, the team at specialty pharma Tenax Therapeutics (NASDAQ; TENX) is working to develop levosimendan to become the first approved treatment in the U.S. for PH-HFpEF. Levosimendan, a calcium sensitizer that works through a triple mechanism of action, was originally developed as an IV drug for acute decompensated heart failure, ultimately earning approval in 60 countries outside the U.S. for the indication. In 2013, Tenax acquired the rights to develop and commercialize levosimendan in North America from Phyxius Pharma.

The company is looking to leverage data from clinical studies in patients with right heart failure and pulmonary hypertension that suggest levosimendan may be an effective therapy in treating PH-HFpEF. The therapeutic effects of levosimendan are further supported by over one million patients being treated with the drug in the countries where it is approved.

More than 2.5 million Americans suffer from HFpEF, with pulmonary hypertension present in the majority of these patients. Mortality rates are high – up to 50 percent at five years – and the patients must cope with a poor quality of life owing to very limited exercise capacity.

PH-HFpEF is categorized in Group 2 of the World Health Organization’s breakdown of pulmonary hypertension (PH), whereas PAH is categorized in Group 1. This distinction is important in many ways, including market opportunity. For instance, when it comes to total PH, Group 1 comprises only 3% of prevalence; Group 2 accounts for 68%. Furthermore, there are a litany of drugs approved by the FDA for Group 1 (generating $5+ billion in annual sales), including PDE5 inhibitors, endothelin receptor antagonists, soluble guanylate cyclase stimulators and prostacyclins. Efficacy is not established in Group 2 for any of these, leaving a gaping void in chronic care.

Tenax recently activated the first clinical site, Stanford University School of Medicine, in its Phase 2 trial of levosimendan for PH-HFpEF. The study is being referred to under the acronym “HELP,” short for Hemodynamic Evaluation of Levosimendan in Patients with PH-HFpEF. The study, expected to enroll 36 adult patients, has a primary outcome comparing the levosimendan group against the placebo group with respect to the change from baseline Pulmonary Capillary Wedge Pressure (PCWP) with bicycle exercise after six weeks of therapy.

Multiple secondary outcomes will also be evaluated, including change in Cardiac Index at rest and with exercise, exercise duration via 6-minute walk test and more. In aggregate, the data is

expected to better define criteria for a Phase 3 trial of levosimendan for PH-HFpEF patients in the future.

According to the study’s listing on clinicaltrials.gov, Tenax is targeting completion of the Phase 2 trial in November 2019.

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