RADNOR, PA — Mineralys Therapeutics, Inc. (Nasdaq: MLYS) announced it has completed enrollment in its Phase 2 EXPLORE-OSA trial evaluating lorundrostat in patients with moderate-to-severe obstructive sleep apnea (OSA) and hypertension. The company expects to report top-line results in the first quarter of 2026.
The randomized, double-blind, placebo-controlled crossover study is testing lorundrostat, a selective aldosterone synthase inhibitor, in overweight or obese adults with OSA and high blood pressure. Participants will receive 50 mg of lorundrostat once daily and placebo in sequential treatment periods, with overnight polysomnography monitoring. The trial’s primary endpoint is the absolute change in apnea-hypopnea index after four weeks of treatment, with secondary measures including blood pressure, nighttime blood pressure, and additional sleep and cardiovascular outcomes.
“Obstructive sleep apnea and high blood pressure are biologically linked, with blood pressure rising during upper airway obstruction during sleep,” said David Rodman, MD, Chief Medical Officer of Mineralys Therapeutics. “In dosing lorundrostat at bedtime, we believe it will suppress the majority of aldosterone produced during sleep while maintaining 24-hour blood pressure control. Episodes of nocturnal hypertension are underdiagnosed and lack an effective treatment. This is particularly concerning for patients that also suffer from comorbid OSA, where available treatments—limited to weight loss and positive airway pressure—may not be sufficiently effective. Consequently, there remains a significant unmet need for more effective and targeted treatment options.”
OSA is estimated to affect nearly one billion people globally, including 425 million moderate-to-severe cases. Roughly 80 percent of adults with the condition remain undiagnosed, and untreated OSA carries heightened risks of resistant hypertension, cardiovascular disease, type 2 diabetes, and stroke. In the United States alone, undiagnosed OSA has been estimated to cost nearly $150 billion annually due to related diseases, accidents, and productivity losses.
Hypertension also represents a major public health burden, contributing to more than 685,000 U.S. deaths in 2022 and carrying an economic impact of roughly $219 billion annually. Dysregulated aldosterone production drives high blood pressure in about 30 percent of hypertensive patients, making it a critical therapeutic target.
Mineralys said positive results from EXPLORE-OSA could complement findings from its earlier EXPLORE-CKD trial and further establish lorundrostat’s potential role in treating hypertension complicated by comorbid conditions.
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