Tenax Therapeutics announced that the prespecified Blinded Sample Size Re-estimation of the LEVEL study showed the trial is powered at well over 90% to detect a 25 meter change in 6MWD, the primary endpoint.
The target enrollment for the ongoing LEVEL study remains unchanged, and enrollment is expected to complete in the first half of 2026.
The company initiated the global Phase 3 LEVEL-2 study, aiming to complete enrollment by the end of 2027.
BSSR Results
The Blinded Sample Size Re-estimation confirmed the study's power to detect significant changes in the primary endpoint.
Enrollment Update
The target enrollment for LEVEL study remains on track, with completion expected in the first half of 2026.
LEVEL-2 Initiation
The company started the global Phase 3 LEVEL-2 study, targeting completion of enrollment by the end of 2027.
- The successful BSSR results provide confidence in the study's design and execution.
- Initiation of the Phase 3 LEVEL-2 study indicates the company's commitment to advancing novel cardiopulmonary therapies.
Tenax Therapeutics' positive BSSR outcomes and enrollment progress in the LEVEL study highlight the company's dedication to developing innovative treatments for cardiopulmonary conditions.