CHAPEL HILL, N.C. — Tenax Therapeutics’ experimental heart-failure drug TNX-103 failed to meet the main goal of a pivotal Phase 3 clinical trial, dealing a setback to the company’s effort to develop an oral treatment for pulmonary hypertension associated with heart failure with preserved ejection fraction.
The LEVEL trial found that TNX-103, an oral formulation of levosimendan, did not significantly improve patients’ six-minute walking distance compared with placebo, according to information released by the company on Monday. The six-minute walk test was the study’s primary efficacy measure. A secondary measure assessing patient-reported symptoms also failed to meet its target, according to the Wall Street Journal.
The trial enrolled more than 230 patients in the United States and Canada and was designed to evaluate whether daily oral levosimendan could improve exercise capacity in people with pulmonary hypertension caused by heart failure with preserved ejection fraction, or PH-HFpEF. Tenax had previously said the study was powered at more than 90% to detect a 25-meter change in six-minute walking distance.
The result represents a setback for Tenax’s lead development program. The company had described PH-HFpEF as an area with no approved therapies and was developing TNX-103 as a potential treatment for the condition. The Phase 3 LEVEL study was intended as a registrational trial, with a second Phase 3 study, LEVEL-2, also part of the company’s development program.
Levosimendan has previously produced encouraging findings in earlier research. Tenax said a Phase 2 study, known as HELP, showed improvements in exercise capacity and cardiovascular hemodynamics among patients with PH-HFpEF. Those findings provided the basis for advancing the oral formulation into late-stage testing.
Tenax’s shares fell sharply following the trial announcement, with the stock dropping nearly 90% on Monday, reflecting the significance of the failed late-stage study for the company, according to the Wall Street Journal.
The company had planned to present detailed LEVEL results at the European Society of Cardiology Congress in Munich on Aug. 29. Tenax had announced in July that the presentation was scheduled as a late-breaking clinical science session.
