Tenax Therapeutics has temporarily paused enrollment in its Phase 3 LEVEL-2 clinical trial for its drug candidate TNX-103 (levosimendan) in patients with pulmonary hypertension in heart failure with preserved ejection fraction (PH-HFpEF). The pause allows the company to amend the trial's protocol and enrich the enrollment criteria based on key findings from the recently completed Phase 3 LEVEL trial, aiming to enroll patients most likely to respond to the treatment.
Key Details
- Trial Affected: Phase 3 LEVEL-2 clinical trial for TNX-103 (oral levosimendan).
- Reason for Pause: To amend the trial's enrollment criteria to focus on a patient sub-population identified in the prior LEVEL trial as being most likely to demonstrate improved exercise tolerance.
- Regulatory Action: The company has requested a Type C meeting with the U.S. Food and Drug Administration (FDA) to discuss the overall development plan for levosimendan.
- Next Steps: Enrollment is expected to resume on a site-by-site basis as the amended protocol is implemented. The pause is not related to safety concerns.