Heart failure drug trials expand as Tenax starts second Phase 3 study

Tenax Therapeutics (NASDAQ: TENX) reported that a prespecified blinded sample size re-estimation (BSSR) for the Phase 3 LEVEL trial showed the study is powered at >90% to detect a 25-meter change in 6-minute walk distance (6MWD), with observed standard deviation in the first 150 randomized patients below the assumed 55 meters. Tenax confirmed no increase in target enrollment and reiterated that LEVEL enrollment is expected to complete in the first half of 2026, with topline data expected in the second half of 2026.

The company also initiated LEVEL-2, a global Phase 3 trial planning ~540 patients randomized 2:1 (TNX-103 vs placebo) with primary endpoint 6MWD at Week 26, selecting >100 sites across 15 countries and estimating enrollment completion by end of 2027. Tenax will open a global open-label extension to provide continued access to TNX-103.

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