Tenax Therapeutics confirmed that its prespecified blinded sample‑size re‑estimation for the LEVEL Phase 3 trial shows the study is powered at well over 90 % to detect a 25‑meter improvement in 6‑minute walk distance. The analysis, based on the first 150 randomized patients, revealed a standard deviation lower than the 55‑meter assumption, allowing the company to keep the original enrollment target of 230 patients and maintain the projected first‑half‑2026 completion date.
The company also announced the launch of LEVEL‑2, a second global Phase 3 study that will enroll roughly 540 PH‑HFpEF patients across 15 countries. Patients will be randomized 2:1 to oral levosimendan (TNX‑103) or placebo, with the primary endpoint of change in 6‑minute walk distance at week 26. Secondary endpoints include the Kansas City Cardiomyopathy Questionnaire and NYHA functional class. Tenax plans a two‑year enrollment timeline and a six‑month blinded safety observation period to support regulatory submissions.
These milestones accelerate Tenax’s development roadmap. By confirming the statistical robustness of LEVEL and initiating LEVEL‑2, the company reduces the risk of enrollment shortfalls and positions itself to generate topline data in the second half of 2026, potentially shortening the path to regulatory approval and market entry. The updates also provide a clearer cash‑burn forecast, as the company will need to fund two concurrent Phase 3 trials, underscoring the importance of its $99.4 million cash reserve and the need for future capital raises if timelines shift.
CEO Chris Giordano said the BSSR outcome is a “derisking element built into the LEVEL protocol from the start” and that the company remains confident in executing the Phase 3 development plan. He added that the launch of LEVEL‑2 demonstrates continued progress and a robust development pipeline for TNX‑103, the oral levosimendan candidate for PH‑HFpEF.
Tenax is the only company with a Phase 3 treatment for PH‑HFpEF, a condition with no approved therapies. The company’s extensive patent protection for levosimendan through at least 2040 and the FDA’s streamlined regulatory pathway position TNX‑103 as a potential first‑in‑class therapy that could address a significant unmet medical need.
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