Tenax raises $100M to accelerate development of oral levosimendan
Therapy is potential treatment for PH-HFpEF
Tenax Therapeutics has raised about $100 million in private funding to help accelerate the clinical development of oral levosimendan (TNX-103), a potential therapy for pulmonary hypertension(PH) due to heart failure with preserved ejection fraction (PH-HFpEF).
The funding will help complete the ongoing placebo-controlled Phase 3 LEVEL trial (NCT05983250) and its open-label extension (OLE) phase where all the patients will be treated with oral levosimendan. Also, Tenax will use the funds toward a second global Phase 3 study, planned for 2025. The protocol for this study will be submitted to the U.S. Food and Drug Administration for comments. This should help shorten the time for a new drug application (NDA) toward the therapy’s approval to be filed.
“We are now funded through completion of the ongoing Phase 3 LEVEL study, including its open-label extension. This funding should also enable us to initiate all sites and advance enrollment in a second, global Phase 3 study,” Chris Giordano, president and CEO of Tenax, said in a company press release. “The proceeds position us to accelerate our ongoing Phase 3 development program and shorten the time to NDA submission.”
In PH-HFpEF, the heart pumps a normal amount of blood with each heartbeat, but the heart muscle is abnormally stiff and fails to relax properly. As a result, the heart’s left pumping chamber (left ventricle) isn’t able to keep up with the blood returning from the lungs, leading to PH.
Levosimendan is thought to help relax blood vessels by activating a potassium channel and reduce the amount of blood putting pressure on vessel walls. It may also help protect the heart muscle, while promoting heart contraction.
Tenax is developing distinct formulations of levosimendan, following a licensing agreement with its original developer, Orion Corp. The company is developing it as an oral medicine, as a therapy to be injected under the skin (TNX-102), and as an injection into the vein (TNX-101). All are protected by a patent that’s valid through 2040.
On the LEVEL
The LEVEL trial, which is recruiting adults with PH-HFpEF, ages 18-85, at several U.S. sites, is assessing the efficacy of levosimendan to improve exercise capacity over 12 weeks, or about three months. Participants will be randomly assigned to receive oral levosimendan at 2 mg/day for weeks one to four and then at 3 mg/day up to week 12, or a placebo. Exercise capacity will be assessed with the six-minute walk distance test, which measures the distance a person can walk over six minutes on a hard, flat surface.
Patients will have the option to enroll in a 92-week OLE after they complete the study’s first 12 weeks.
“The Tenax team looks forward to completing the Phase 3 studies of oral levosimendan in treatment of PH-HFpEF patients, the only therapy shown to produce favorable hemodynamic changes and improve exercise tolerance in these patients,” Giordano said.
In the Phase 2 HELP trial (NCT03541603), weekly infusions of TNX-101 in adults with PH-HFpEF reduced pressure on the heart and improved exercise capacity after six weeks over a placebo.
Switching from infusions into the vein to oral levosimendan was well tolerated and further improved patients’ exercise capacity, according to the OLE data.
“Participants in the HELP study showed an approximate 10% improvement of 29 meters in their six-minute walk distance over a six-week period, making levosimendan the first drug to show exercise improvement in any patients with HFpEF, with or without PH,” said Stuart Rich, MD, Tenax’s chief medical officer. “In a subsequent open-label study, patients showed further improvement in exercise capacity when transitioned from weekly IV to oral daily therapy.”
The investment was led by BVF Partners LP, with the support of several others, including Venrock Healthcare Capital Partners, Vivo Capital, Janus Henderson Investors, and more.
“This transformational financing is a significant commitment by top-tier biotech investors who believe in levosimendan’s potential to impact the lives of patients suffering from PH-HFpEF,” Giordano said.
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