On October 8, 2026, Tenax Therapeutics, Inc. filed an 8-K report announcing that it has paused enrollment in its LEVEL-2 clinical trial. The company stated that it intends to amend the enrollment criteria for the trial based on key learnings from its recently completed Phase 3 LEVEL trial of TNX-103 in patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF).
The company explained that the LEVEL-2 trial is designed to maximize enrollment for patients who, according to LEVEL results, are most likely to demonstrate an improvement in exercise tolerance. To facilitate this, the Company has temporarily paused enrollment at all sites while it updates the protocol to reflect the new criteria. Enrollment is expected to resume at individual sites as the amended protocol goes into effect.
In the filing, Tenax disclosed that the LEVEL trial did not meet its primary endpoint of a change in 6-minute walk distance (6MWD) in the overall enrolled population. However, the company’s Investor Presentation attached to the filing suggests that the trial results were driven by patient selection rather than the drug's effect. The presentation indicates that the primary endpoint was missed because too many patients walked too far at baseline to show significant improvement, and it proposes that the LEVEL-2 trial is de-risked by focusing on a more limited patient population.
The Company also stated that it has requested a Type C meeting with the U.S. Food and Drug Administration to discuss the overall development of levosimendan. The filing includes an updated corporate presentation dated October 8, 2026, which details the trial design, patient demographics, and safety data from the LEVEL trial.
