Levosimendag Treatment for PH-HFpEF Set for Major Spotlight at Tenax Therapeutics Forum

Tenax Therapeutics’ investigational therapy is gaining momentum in the cardiovascular field as leading experts prepare to discuss its potential at a premier industry conference. A distinguished medical researcher from Northwestern University will take the stage at THT 2024 in Boston to present compelling data on the use of levosimendag—a novel therapeutic approach aimed at addressing pulmonary hypertension in patients with heart failure and preserved ejection fraction (PH-HFpEF).

The Clinical Need and Therapeutic Promise

PH-HFpEF represents a significant healthcare challenge with limited treatment options and considerable patient morbidity. The condition combines two serious cardiac complications, creating what the American Heart Association has characterized as a “growing epidemic” demanding urgent therapeutic innovation. Current medical practice offers no proven drug therapy that substantially improves exercise capacity in this patient population, highlighting a critical gap in cardiovascular treatment options.

Tenax Therapeutics has positioned itself at the forefront of addressing this unmet need through its multi-platform development approach. The company maintains global rights to develop both intravenous and oral formulations of levosimendag—a potassium ATP channel activator and calcium sensitizer that operates through multiple therapeutic pathways to influence cardiac and vascular function.

The Research Evidence

Earlier Phase 2 clinical findings provided proof-of-concept for this approach. The HELP study demonstrated that intravenous levosimendag delivery produced pronounced dilation of central and pulmonary venous circulation, which translated into measurable improvements in patients’ exercise tolerance—a breakthrough distinct from other available therapies in this indication.

Building on these findings, Tenax Therapeutics has advanced to Phase 3 clinical development with the LEVEL study, a double-blind, randomized, placebo-controlled investigation enrolling approximately 152 subjects. Participants receive either oral levosimendag (2 mg/day for the first four weeks, escalating to 3 mg/day for weeks five through twelve) or placebo, with six-minute walk distance serving as the primary efficacy endpoint measured at week 12.

Forum Presentation and Industry Recognition

The upcoming presentation at Technology and Heart Failure Therapeutics (THT) Conference on March 6, 2024, represents validation of this research direction. Dr. Sanjiv Shah, Stone Endowed Professor of Medicine at Northwestern University’s Feinberg School of Medicine and Director of the HFpEF Program, will present the scientific rationale during a dedicated pulmonary hypertension treatment session.

THT 2024, hosted at the Westin Boston Seaport from March 4-6, convenes an international multidisciplinary audience of heart failure specialists, interventional cardiologists, and healthcare innovators. The conference emphasizes emerging technologies and pharmaceutical innovations in heart failure management, making it an appropriate venue for advancing understanding of Tenax Therapeutics’ candidate therapy.

Development Timeline and Future Outlook

The transition from Phase 2 to Phase 3 clinical investigation marks a critical juncture for levosimendag’s development trajectory. All subjects completing the 12-week core study have the opportunity to enroll in an extended 92-week open-label extension phase, providing extended safety and efficacy data. This extended observation period supports long-term clinical characterization of the therapy.

Levosimendag itself is not entirely novel to global medicine—intravenous formulations developed by Orion Corporation in Finland have received approval in 60 countries for hospitalized patients with acute decompensated heart failure. Tenax Therapeutics’ contribution centers on developing oral delivery systems and expanding therapeutic applications, addressing the distinct needs of ambulatory patients with chronic pulmonary hypertension.

The company simultaneously pursues complementary development programs, including an investigational oral imatinib formulation, diversifying its portfolio within cardiovascular and pulmonary disease spaces. Tenax Therapeutics trades on Nasdaq under the symbol TENX and continues focused advancement toward addressing diseases with substantial unmet medical need.