Tenax Therapeutics, Inc. Study result
Review the key takeaways and the transcript of this earnings call.
- Tenax Therapeutics reported top line results from their phase three LEVEL trial of oral levosimendan in patients with pulmonary hypertension and heart failure with preserved ejection fraction (pH HFpEF).
- The primary endpoint, change in six minute walk distance at week 12, did not reach statistical significance with a treatment difference of 3.5 meters and a p value of 0.63.
- Levosimendan showed a 49% reduction in NT-proBNP compared to placebo and a 3.5 mmHg reduction in pulmonary artery systolic pressure, both statistically significant.
- Subgroup analyses revealed that patients with baseline six minute walk distance below the median of 333 meters experienced a placebo-corrected improvement of 26.3 meters (p=0.0112).
- Patients with higher baseline walk distances showed a negative treatment difference, with placebo outperforming levosimendan by 17.6 meters.
- The drug was generally well tolerated with adverse events consistent with prior studies; serious adverse events and mortality rates were similar between levosimendan and placebo arms.
- The trial enrolled 241 patients across 41 sites in the US and Canada, with high adherence and retention rates.
- The patient population was well treated with standard HFpEF therapies including SGLT2 inhibitors, GLP-1 receptor agonists, MRAs, and diuretics.
- Key secondary endpoints such as KCCQ total symptom score and NYHA functional class improvement did not reach statistical significance.
- Two deaths occurred in the levosimendan arm during the double-blind phase, both deemed unrelated to the drug.
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Transcript
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Good day. Welcome to the Tenax Therapeutics phase III LEVEL Top Line Results Conference Call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by zero. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star, then one on a touch-tone phone. To withdraw your question, please press star, then two. Please note, this event is being recorded. I would now like to turn the conference over to Chris Giordano, President and Chief Executive Officer.
Please go ahead. Good morning, everyone.
Thank you, Betsy. Thank you everyone for joining us. I'm Chris Giordano, President and Chief Executive Officer of Tenax Therapeutics. This morning, we released top line results from LEVEL, our first phase III trial of oral levosimendan in patients with PH-HFpEF. The primary endpoint did not reach statistical significance. The difference between groups in six-minute walk distance at week 12 was 3.5 meters with a P value of 0.63. The evidence we will share with you today impresses us. Levosimendan's impact on key objective biological targets directly translates benefit from pulmonary pressure and BNP lowering to functional improvement in the more advanced patients we treated. We believe we have a drug for the many patients who need it, and there are millions of them around the world. Our phase II HELP results found a new target population for this unique drug.
LEVEL was always intended to validate the efficacy shown in that study, more precisely measure the treatment effect, and establish the right patients who benefit in this very heterogeneous HFpEF population. The trial did not meet its primary objective. When it comes to sizing and locating the treatment effect in these patients, the trial has achieved very important goals. We received data only last week. In beginning to dissect it, we see evidence of a very responsive patient population in LEVEL, and we also see the reason their response is obscured in measurement of the primary endpoint. We see clearly where one inclusion criterion let this drug down in this study. What I will tell you today is this: our therapy works very effectively in a large, common, easily identifiable population of PH-HFpEF patients, and they need it.
We are not in a situation where the drug and the placebo groups are indistinguishable in our data, or a situation where drug exposure or adherence was inadequate in the trial, at least not in the full analysis set we're looking at. On the contrary, our results define the population of high responders coherently, and the adjustment we need to make in our phase III program is crystal clear. LEVEL was a well-conducted trial. It was executed on time, randomizing 241 patients in about 24 months, with a reassuring 2% rate of missingness on the primary endpoint. Very high patient retention and therapy adherence, and no site-specific problems or six-minute walk test performance anomalies we're going to point to as a culprit behind the primary miss. We have invaluable information from LEVEL, and we intend to use it.
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