Tenax Advances Levosimendan Into Phase 2 Trial for PH Caused by Heart Disease

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Tenax Advances Levosimendan Into Phase 2 Trial for PH Caused by Heart Disease

Tenax Therapeutics plans to advance its lead compound, levosimendan, into a Phase 2 clinical trial to treat pulmonary hypertension (PH) associated with heart failure and preserved ejection fraction (PH-HFpEF) — a type of PH related to left heart disease.

The company, based in Morrisville, North Carolina, aims to start the clinical trial in late 2018, prompted by the positive feedback of clinical experts on PH and promising preliminary studies of the compound in PH-HFpEF patients.

Fewer than half of the 1.5 million Americans believed to have PH-HFpEF survive more than five years. No treatment is available for this disease, which encouraged Tenax to invest in a therapy for the illness.

Some of possible favorable effects of levosimendan include the ability to improve right heart failure — a common condition among PH-HFpEF patients — and lower elevated pulmonary wedge pressures.

“PH-HFpEF is a serious public health problem that is becoming a common cause of pulmonary hypertension for which there are no effective treatments,” Dr. Stuart Rich, MD, director of the Pulmonary Vascular Disease Program at Chicago’s Bluhm Cardiovascular Institute, said in a press release. “The novel mechanisms of action of levosimendan, supported by published data from trials in pulmonary hypertension, as well as left and right ventricular failure, provide a strong rationale for the development of levosimendan in PH-HFpEF.”

Levosimendan is a calcium sensitizer known for its ability to increase heart contractibility, as well as its vasodilatory and cardioprotective effects. Doctors currently use it to treat heart failure in hospitalized patients. The drug has not won regulatory approval from the U.S. Food and Drug Administration (FDA); in European countries, it’s sold under the label Simdax.

Tenax owns the U.S. rights to commercialize and develop levosimendan, and recently completed a Phase 3 clinical trial for a levosimendan-based medicine, LEVO-CTS, to improve clinical outcomes in patients who undergo cardiac surgery.

The company now hopes to speed clinical development of levosimendan as a therapy for PH-HFpEF, and already asked the FDA for pre-investigational drug approval.

“Our advisors’ strong support for this development plan, combined with the significant commercial value that it could represent, makes us very excited to execute this new clinical development strategy.” said Tenax’s interim CEO, Michael Jebsen.

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