HELP Trial for Levosimendan Adds 3 Sites, Expects Full Enrollment Soon

A Phase 2 clinical trial for levosimendan, a potential treatment for pulmonary hypertension (PH) and heart failure with preserved ejection fraction (PH-HFpEF), will soon have three more active sites for participant enrollment, Tenax Therapeutics announced.

There now are 12 clinical sites that have initiated the study, and it is expected that the additional three will join over the next few weeks. With this expansion, the company believes it will achieve the target number of participants planned for the study. For more information on trial locations and contacts, please visit the webpage here.

“We are pleased with the progress made over the past few months [in] advancing the Phase 2 trial,” Anthony DiTonno, CEO of Tenax Therapeutics, said in a press release. “We now expect full enrollment and top-line data in the HELP Trial in the first quarter of 2020.”

Levosimendan belongs to a class of compounds known as calcium sensitizers. It works through a unique mechanism of action that helps improve contraction of the heart muscles without increasing the requirement for oxygen.

Tenax is investigating the safety and efficacy of levosimendan in patients with PH-HFpEF in a multi-center, double-blind, placebo-controlled clinical trial (NCT03541603) called HELP (Hemodynamic Evaluation of Levosimendan in Patients with PH-HFpEF).

Ejection fraction refers to how much blood is pumped by the heart with each beat. In people with PH-HFpEF, the heart muscles are too weak to pump properly despite the fact that the heart beats normally.

The trial is expected to enroll approximately 36 adults with confirmed PH-HFpEF who will be randomly assigned to received weekly infusions of levosimendan or a similar dose of placebo, for six weeks. This short-term study will evaluate the impact of the investigational treatment on the exercise capacity of the PH-HFpEF patients.

To date, eight participants have been enrolled in the trial. Three have already completed the initial 6-week protocol and have been transferred over into a 2-year, open-label, extension-phase study (NCT03624010).

In this long-term study, all participants will receive weekly treatment with levosimendan. Researchers will evaluate the overall safety of the therapy and its effects on patients’ outcomes, including exercise capacity, well-being, and hospitalization rates.

“Based on feedback from our principal investigators we have modified and adapted our protocols for the HELP trial. These modifications, in addition to achieving our targeted number of clinical sites, have resulted in an acceleration in the pace of patient enrollment,” DiTonno said.

Tenax also announced it is working on a new method of drug administration for levosimendan. The company has developed, and recently filed a patent application for a subcutaneous formulation of levosimendan. That would allow the therapy to be administered by injections under the skin, instead of the current formulation which requires intravenous (into the vein) infusions.

“Future development activities will be finalized following the completion of our Phase 2 HELP trial and subsequent discussion with the FDA [U.S. Food and Drug Administration] on a Phase 3 trial for PH-HFpEF patients,” he said.