Tenax Therapeutics announced the outcome of the prespecified Blinded Sample Size Assessment for the LEVEL trial.
The assessment demonstrated that the trial is well powered to detect a 25 meter change in 6-minute walk distance, the primary endpoint.
Enrollment for the LEVEL trial is on track to be completed in the first half of 2026 with topline data expected in the second half of 2026.
Confirmed Enrollment Target
Target enrollment for the LEVEL trial remains unchanged after the assessment.
High Study Completion Rate
High rate of study completion observed in the assessment of the first two-thirds of patients in LEVEL.
Initiation of LEVEL-2 Study
Tenax Therapeutics initiated the global Phase 3 LEVEL-2 study for TNX-103 in patients with PH-HFpEF.
Rigorous Site Selection Process
Implemented a rigorous process to identify global sites consistent with successful sites in the U.S. and Canada for LEVEL-2.
- The BSSR results provide confidence in the powering assumptions based on Phase 2 trial data.
- Initiation of the LEVEL-2 study expands the clinical development plan for TNX-103 in PH-HFpEF patients.
- Selection of over 100 sites across 15 countries for the LEVEL-2 study indicates a broad global reach.
Tenax Therapeutics remains confident in the execution of their Phase 3 development plan for TNX-103, with topline data expected in the second half of 2026. The initiation of the global Phase 3 LEVEL-2 study further strengthens the company's commitment to addressing PH-HFpEF.