Tenax Therapeutics announces the results of the Prespecified Blinded Sample Size Assessment for its ongoing clinical trial, LEVEL.
The assessment confirmed that the trial is well powered to detect a 25 meter change in 6MWD, the primary endpoint.
Enrollment for the trial is expected to complete in the first half of 2026 with topline data expected in the second half of 2026.
BSSR Outcome
The Prespecified Blinded Sample Size Re-estimation confirmed the trial's power to detect the primary endpoint change.
Enrollment Progress
The target enrollment for the trial remains unchanged with completion anticipated in the first half of 2026.
New Study Initiated
Tenax Therapeutics has initiated a global Phase 3 study, LEVEL-2, evaluating TNX-103 in PH-HFpEF patients.
- The successful outcome of the BSSR provides confidence in the trial's progress and eventual results.
- Initiation of the LEVEL-2 study expands the company's clinical development pipeline for PH-HFpEF treatments.
Tenax Therapeutics continues on track in its Phase 3 development plan for TNX-103, with multiple studies underway to evaluate the potential treatment for PH-HFpEF.