Tenax Therapeutics, Inc. (TENX) announced an expansion of its Phase 3 LEVEL program for TNX-103 or oral levosimendan, a novel treatment for pulmonary hypertension with heart failure with preserved ejection fraction or PH-HFpEF.
The expansion includes two key developments:
-- Tenax has received approval from the FDA to enlarge its LEVEL study, increasing the enrollment from 152 to 230 patients. This expansion enhances the statistical power of the study to over 95 percent, with expected completion of enrollment by the end of 2025.
-- The company has also received FDA approval to initiate LEVEL-2, a global Phase 3 study for TNX-103 in PH-HFpEF, with the first patient expected to be enrolled later this year. This study aims to provide a robust safety database for regulatory submissions.
In early data from the LEVEL study, TNX-103 has shown to be well-tolerated in patients, with more than 95 percent of patients remaining on therapy, demonstrating high adherence and no new safety concerns.
These two registrational studies are critical steps for Tenax in advancing TNX-103 as a potential first-line treatment for PH-HFpEF, a disease with significant unmet needs and no currently approved therapies.
The company plans to submit the data for regulatory approval in the U.S. and other markets once the studies are complete.
Currently, TENX is trading at $5.94 down by 1.80 percent on the Nasdaq.
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