Tenax Therapeutics announced the FDA’s acceptance of an amendment to expand its Phase 3 LEVEL study for TNX-103 (oral levosimendan) in patients with pulmonary hypertension associated with heart failure with preserved ejection fraction (PH-HFpEF). The LEVEL study will now enroll 230 patients, increasing its statistical power, and a second global Phase 3 trial, LEVEL-2, will commence in 2025. These parallel studies aim to provide sufficient data for regulatory filings in the U.S. and other regions.
This development is crucial for PH-HFpEF patients, a population currently lacking approved treatments. The expansion of LEVEL and the initiation of LEVEL-2 signal a significant step towards potentially providing a much-needed therapy for this serious condition, offering hope for improved quality of life and addressing a high unmet medical need. The progress made by Tenax Therapeutics with TNX-103 underscores a shift in the landscape for PH-HFpEF management.
The LEVEL study, now targeting 230 patients, is expected to complete enrollment by the end of 2025, with topline data anticipated mid-2026. Interim data from LEVEL shows that TNX-103 is well-tolerated, with high patient retention rates in both the active treatment and open-label extension phases. LEVEL-2, a larger global study, will evaluate patients for a full year, generating a more comprehensive safety database. Both studies are placebo-controlled and evaluate changes in six-minute walk distance, a key measure of functional capacity in these patients.
This two-pronged approach strengthens Tenax Therapeutics’ position in developing a first-in-class therapy for PH-HFpEF. The positive interim data, coupled with the expanded LEVEL study and the launch of LEVEL-2, sets a clear path towards regulatory submission. The expected data readouts in 2026 hold significant potential to transform the treatment paradigm for this underserved patient population.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
