Tenax Therapeutics announced topline results from its Phase 3 LEVEL clinical trial for TNX-103 in patients with pulmonary hypertension associated with heart failure (PH-HFpEF), reporting that the study did not meet its primary endpoint. The drug failed to show a statistically significant improvement in the 6-minute walk distance (6MWD) compared to placebo.
Despite the primary endpoint failure, the company highlighted positive results from a prespecified subgroup of patients with more severe disease and intends to meet with the FDA to discuss a path forward for the drug's development.
Key Details
- Primary Endpoint: The trial did not achieve statistical significance, showing a 3.5-meter improvement in 6MWD versus placebo (p=0.63).
- Subgroup Analysis: In a prespecified subgroup of patients with a baseline 6MWD below the trial median of 333 meters, TNX-103 showed a 26.3-meter improvement compared to placebo (nominal p=0.0112).
- Biomarker Data: In exploratory analyses, TNX-103 demonstrated a 49% greater reduction in the NT-proBNP biomarker compared to placebo (nominal p<0.0001), a measure of cardiac wall stress.
- Next Steps: Tenax plans to request a Type C Meeting with the U.S. FDA to discuss revisions to the registrational development of TNX-103 based on the trial's findings.