Tenax Therapeutics announced the results of the prespecified Blinded Sample Size Re-estimation for the ongoing LEVEL study.
The trial is well powered to detect a 25 meter change in 6-minute walk distance (6MWD), the primary endpoint.
Enrollment for the study is on track to complete in the first half of 2026 with topline data expected in the second half of 2026.
Level Study Empowered
The BSSR confirmed the trial's power of over 90% to detect the primary endpoint change in 6MWD.
Target Enrollment Unchanged
The target enrollment for the LEVEL study remains unchanged based on the BSSR results.
Initiation of LEVEL-2 Study
The company has initiated the global Phase 3 LEVEL-2 study for TNX-103 in patients with PH-HFpEF.
Enrollment Strategy
The company has selected over 100 sites in 15 countries for the LEVEL-2 study with a total enrollment timeline estimation of around two years.
Safety Observation in LEVEL-2
A cohort of patients in LEVEL-2 will undergo a safety observation following the efficacy assessment to support regulatory analysis.
- The BSSR results have provided reassurance and validation for Tenax Therapeutics' Phase 3 development plan for levosimendan in PH-HFpEF.
- The initiation of the LEVEL-2 study marks an important milestone in the company's efforts to bring novel cardiopulmonary therapies to patients globally.
Tenax Therapeutics shows promising progress with the BSSR results and the initiation of the global Phase 3 LEVEL-2 study, reinforcing its commitment to advancing treatment options for patients with pulmonary hypertension in heart failure.