First Clinical Site Announced for Phase 2 Trial Testing Levosimendan for PH Linked to Heart Disease

The Stanford University School of Medicine is the first clinical site for a Phase 2 trial testing levosimendan as a potential treatment for pulmonary hypertension associated with heart failure and preserved ejection fraction (PH-HFpEF), Tenax Therapeutics recently announced.

Ejection fraction is the amount of blood that the left chamber of the heart pumps at every beat. PH-HFpEF occurs when the heart beats normally, but the muscles are too weak to pump and fill blood properly.

Levosimendan is a calcium sensitizer that improves the contraction of the heart muscles by increasing its sensitivity to calcium, and helps dilate blood vessels (vasodilation effects). The therapy is not yet approved for use in the United States; however, in more than 60 other countries, levosimendan is used for the treatment of acute heart failure in hospitalized patients.

It is marketed in Europe as Simdax by Orion Pharma. Tenax Therapeutics obtained the rights to develop and commercialize this therapy in the U.S.

The Phase 2 trial (NCT03541603), called HELP, is expected to recruit a total of 36 patients at about 12-15 different research institutions across the U.S.

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It will evaluate the safety and efficacy of levosimendan, including the ability to improve heart function. Enrolled PH-HFpEF patients will randomly receive either a placebo or levosimendan.

“We are very excited to have activated our first site for the HELP trial. We are equally excited that so many highly regarded medical centers and principal investigators have indicated strong interest in participating in the trial and we expect to have several additional site activations in the coming weeks,” Anthony DiTonno, CEO of Tenax Therapeutics, said in a press release.

According to the company, promising data from preclinical and clinical studies in pulmonary hypertension (PH) and heart failure patients support levosimendan’s potential benefits for patients with PH-HFpEF.

In a PH rat model, levosimendan therapy was found to improve the heart’s right ventricular function.

Similarly, data from clinical trials provided encouraging results. A Phase 3 trial in particular showed that levosimendan therapy improved kidney function in PH-HFpEF patients. Kidney function is commonly impaired in patients with heart failure.

Results from the HELP trial will guide the Phase 3 development plan for levosimendan as a potential therapy for PH-HFpEF.