Mineralys Therapeutics (MLYS), a clinical-stage biopharmaceutical company, has completed enrollment in its phase 2 trial evaluating lorundrostat for moderate to severe obstructive sleep apnea and hypertension, dubbed EXPLORE-OSA trial.
Lorundrostat is the company's lead drug candidate, an orally administered, highly selective aldosterone synthase inhibitor for the treatment of uncontrolled or resistant hypertension, chronic kidney disease, and obstructive sleep apnea. Lorundrostat works by targeting CYP11B2, the enzyme responsible for producing aldosterone.
Obstructive Sleep Apnea is a common sleep disorder characterized by repeated breathing pauses and starts during sleep due to blockage of the upper airway.
With participant enrollment being completed, the company now expects to analyze and report top-line results of the EXPLORE-OSA trial in the first quarter of 2026.
The EXPLORE-OSA trial is a randomized, Phase 2 double-blind, placebo-controlled, crossover trial designed to evaluate the efficacy, safety, and tolerability of lorundrostat in overweight or obese adults with moderate-to-severe obstructive sleep apnea (OSA) and hypertension.
The primary endpoint of the trial is the absolute change from baseline in apnea-hypopnea index after four weeks of active treatment compared to placebo. Secondary endpoints include changes in blood pressure, nighttime blood pressure, and additional sleep and cardiovascular health.
Upon successful trial completion, the data will complement the previously announced positive topline results from its EXPLORE-CKD trial of Lorundrostat.
MLYS closed Tuesday's trading 3.63% lower at $37.92 on the Nasdaq.
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