Tenax Therapeutics (TENX) Study result summary

Study design and execution

• LEVEL was a phase III, double-blind, randomized, placebo-controlled trial in PH-HFpEF, enrolling 241 patients across 41 sites in the US and Canada over 24 months, with balanced baseline characteristics and specific hemodynamic inclusion criteria.

• Patients received oral levosimendan (TNX-103), titrated over 12 weeks, or placebo, with an open-label extension ongoing.

• About half of patients had a baseline six-minute walk distance (6MWD) below 333 meters, and most were on standard HFpEF therapies.

• High patient retention, adherence, and low missing data rates were achieved.

• An open-label extension for up to two years is ongoing.

Primary and secondary endpoint results

• The primary endpoint was not met: the difference in six-minute walk distance at week 12 was 3.5 m (p=0.63).

• Both levosimendan and placebo groups improved, with a treatment difference of 3.5–8 m depending on analysis.

• The key secondary endpoint (KCCQ total symptom score) showed no significant difference between groups.

• Clinical worsening events and serious adverse events were balanced between arms.

• NT-proBNP, a biomarker of heart failure, was reduced by 49% vs placebo (p<0.0001) in the overall population.

Safety and tolerability

• Levosimendan (TNX-103) was generally safe and well-tolerated, with most adverse events mild to moderate and manageable by dose reduction.

• Serious adverse events and clinical worsening events were similar between groups (10.8% vs 10.7%).

• Two deaths occurred in the levosimendan arm, both deemed unrelated to the drug.

• No new-onset atrial fibrillation or ventricular tachycardia was observed in patients without pre-existing evidence.

• No new safety signals were detected; adverse events were similar between groups.