Tenax’s blinded sample size re-estimation in its Phase 3 LEVEL study indicates the trial retains well over 90% power to detect a 25-meter difference in 6-minute walk distance, with observed variability below the originally assumed standard deviation of 55 meters. With no need to expand enrollment, the company stays on its current timeline: full enrollment in the first half of 2026 and topline data in the second half of 2026.
The company also opened LEVEL-2, a second registrational, global Phase 3 evaluating oral levosimendan (TNX-103) in PH-HFpEF. The study targets approximately 540 patients randomized 2:1 to drug versus placebo, with change in 6-minute walk distance at Week 26 as the primary endpoint and KCCQ and NYHA class as secondary measures. Tenax has lined up more than 100 sites across 15 countries, is emphasizing hemodynamic assessment consistency in site selection, and projects a roughly two-year enrollment window, with completion by the end of 2027. A subset of participants will remain on blinded therapy for an additional six-month safety observation to expand the safety database. In parallel, Tenax plans a global open-label extension to maintain access to therapy post-study and support retention.
Strategically, the BSSR outcome is an operational win. By confirming lower-than-assumed variance in walk distance, Tenax avoids a costly midstream sample size increase and preserves its trial economics and timelines. Initiating LEVEL-2 now signals a commitment to a two-trial registrational package with mirrored endpoints, a pragmatic read of regulatory expectations in a heterogeneous condition with no approved therapies. The global footprint and tighter front-end qualification of sites on hemodynamic phenotyping is aimed at curbing screen failure, reducing misclassification of PH-HFpEF, and harmonizing functional endpoints—pain points that have undermined past HFpEF efforts.
For sites, the program’s design underscores process rigor over novelty. Centers will need standardized right heart catheterization protocols, tightly controlled 6MWD conduct, and consistent capture of KCCQ and NYHA outcomes, likely with central oversight and training. CROs and vendors should anticipate demand for global site start-up, endpoint standardization, ePRO for quality-of-life measures, and supply chain coordination for a long-duration oral therapy. Patients gain structured access to an investigational option in a high-need segment and a defined open-label path after blinded participation. Regulators will receive parallel datasets anchored on functional capacity, augmented by a purpose-built safety cohort—an attempt to preempt questions about durability and tolerability in a comorbidity-heavy population.
The next checkpoints are executional. Watch screen fail rates as PH-HFpEF definitions are operationalized and whether the variance observed in the first 150 randomized patients holds as enrollment broadens globally. The regulatory conversation around 6MWD in this population remains a swing factor; PAH precedent helps, but PH-HFpEF may face higher scrutiny on clinical meaningfulness and translation to outcomes beyond 26 weeks. The safety profile—particularly hemodynamic effects relevant to HFpEF—will be pivotal, and the blinded safety extension is designed to address that. By late 2026, consistency between LEVEL and LEVEL-2 in effect size, site performance, and subgroup behavior will determine whether Tenax’s two-trial strategy compiles into a defensible filing package or requires outcome-oriented augmentation.
Source link: https://www.globenewswire.com/news-release/2025/12/17/3207055/12401/en/Tenax-Therapeutics-Announces-Result-of-Prespecifed-Blinded-Sample-Size-Assessment.html
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.
